Formycon secures license date for aflibercept 2 mg biosimilar FYB203 in Europe and further territories following settlement with Regeneron and Bayer
- Settlement and licensing agreement for FYB203 (AHZANTIVE® and Baiama®) concluded with Regeneron and Bayer; all pending patent litigations fully resolved
- Agreement covers Europe as well as key markets in Latin America and the Asia-Pacific region
- Market launches by commercialization partners across Europe to start in May 2026
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea®1 2 mg biosimilars AHZANTIVE®2 and Baiama®3. Under the terms of the agreement, both products may be launched in Europe and further territories including key markets in Latin America and Asia-Pacific from May 2026. In October 2025, Formycon had already secured the U.S. license date for FYB203 in Q4 2026 as part of an agreement with Regeneron.
“The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners. With our differentiated and regionally focused partnering strategy, we are sure that we have set the course for sustainable success of FYB203 across the European markets and beyond. For ophthalmologists and patients with severe retinal diseases, our biosimilars represent a highly effective and cost-efficient treatment option,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.
AHZANTIVE® and Baiama® are approved by the European Medicines Agency (“EMA”) for the treatment of neovascular age-related macular degeneration (“nAMD”) and other serious retinal diseases. The active ingredient aflibercept inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina, causing severe visual impairment.
1 Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2 AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
3 Baiama® is a registered trademark of Klinge Biopharma GmbH
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich and listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
Formycon AG postpones the publication of its audited annual and consolidated financial statements for 2025
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
Planegg-Martinsried, Germany, March 18, 2026 – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (the “Company”) announces that the publication of the audited 2025 annual and consolidated financial statements, originally scheduled for March 26, 2026, will be postponed.
A key reason is the change to a new internal financial planning system, which was rolled out companywide during the reporting period. Furthermore, in the course of closing process, additional reconciliation and validation work have arisen, requiring more time and documentation than originally anticipated. Against this background, not all documents have been finalized yet, and the required audit measures could not yet be completed.
The publication of the audited annual and consolidated financial statements for the 2025 fiscal year is scheduled for April 2026 and will therefore continue to comply with statutory and stock exchange deadlines. The company will announce the exact date in due course.
Formycon AG publishes preliminary figures for the 2025 fiscal year
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
- Strong increase in Group revenues in the fourth quarter, but full-year revenues still expected to remain below guidance
- Group EBITDA expected to be at the upper end of the expected range
- Adjusted EBITDA as well as working capital expected to be improved versus guidance
Planegg-Martinsried, Germany, March 4, 2026 – Based on preliminary and unaudited figures, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) (“Company” or “Formycon“) expects Group revenues for the 2025 fiscal year to amount to approximately € 45 million. Despite a strong increase in the fourth quarter, total revenues are below the previously communicated forecast range of € 55 million to € 65 million. This is partly due to longer negotiations to conclude further commercialization and development partnerships, for example for the Keytruda®1 biosimilar candidate FYB206, in order to optimize their financial terms. In addition, recognition of milestone events anticipated for Q4 shifted to the first quarter of 2026. Furthermore, while revenue contributions from FYB202 increased significantly in Q4, the product is still in the early phase of commercialization and did not ramp up as quickly as expected.
In this context, based on the results of the impairment test available to date, the company expects that the valuation model and balance sheet measurement for FYB202 will need to be reviewed and adjusted to reflect this slower ramp up. According to Formycon’s commercialization partners, market uptake of FYB202 is developing positively. However, despite encouraging political signals, the pharmacy benefit market (PBM) in the U.S. is still opening only gradually. Based on preliminary calculations, the company expects an extraordinary, non-cash and non-EBITDA-relevant impairment requirement in the low to mid double-digit million range.
The Group’s earnings before interest, taxes, depreciation and amortization (Group EBITDA) for the 2025 fiscal year is expected to amount to approximately € -12 million, at the upper end of the forecast range of € -20 million to € -10 million. Adjusted consolidated earnings before depreciation and amortization (Group adjusted EBITDA), which also shows the total income of the FYB201 ranibizumab biosimilar, is expected to be approximately € -7 million, which is above the most recently communicated forecast range of € -20 million to € -10 million. The significantly better-than-expected at-equity result (approx. € 5 million) from the 50% stake in Bioeq AG mainly benefited from the upfront payment from the partnership of FYB201/Nufymco®2.
The Company expects a further improvement in working capital to approximately € 73 million, which is significantly above guidance. Due to the € 70 million corporate bond placed in July 2025, Formycon had already raised its forecast for this key figure from the original € 25 million to € 35 million to € 55 million to € 65 million upon publication of its half-year results for 2025. Significant upfront payments in connection with initial partnerships for the Keytruda® biosimilar candidate FYB206 in 2025, strict cost management and efficiency improvements contributed to a further increase.
The final financial figures and further information on the 2025 financial year as well as the outlook for 2026 will be published on 26 March 2026 with the annual report for the 2025 financial year on the website.
1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
2) Nufymco® is a registered trademark of Formycon AG
Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)
- Dahlia PK study demonstrates pharmacokinetic equivalence of FYB206 (pembrolizumab) with the reference drug Keytruda®
- Positive clinical data from the pivotal study underline Formycon’s strong position among the leading developers of a pembrolizumab biosimilar
- Focus on completing development and preparing the regulatory dossiers
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, „Formycon“) announces that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multicenter clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda®1.
Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, comments: “Reaching this important milestone in our clinical development program in such a short time reflects our exceptional scientific expertise as well as our strong capabilities in efficiently conducting clinical trials. The positive results of the Dahlia PK study for our biosimilar candidate FYB206 underline our position as one of the leading biosimilar developers for this important biologic drug. They confirm the strategy of our streamlined clinical development program as well as the high quality of our study design and management. We are now one step closer to making FYB206 available worldwide as quickly as possible and improving access to this essential therapy.”
At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda®, based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires. In the meantime, patients from the Dahlia study will continue to be treated to ensure optimum clinical care.
Pembrolizumab is a humanized monoclonal antibody that belongs to the class of immune checkpoint inhibitors and is used to treat various types of cancer. Due to this broad range of indications in oncology, global sales of Keytruda® in 2025 increased by 7% year-on-year to US$ 31.7 billion.2 Keytruda® thus maintains its top position among the world’s best-selling drugs.
1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
2 https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich and listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
Lotus Pharmaceutical becomes commercialization partner for Formycon’s Keytruda® biosimilar candidate FYB206 across major parts of the Asia-Pacific Region
Planegg-Martinsried, Germany and Taipei, Taiwan – Formycon AG (FSE: FYB, “Formycon”) and Lotus Pharmaceutical (“Lotus”) today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda®1 biosimilar candidate FYB206 (Pembrolizumab). Lotus, a multinational pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines will commercialize FYB206 across major parts of the Asia-Pacific (“APAC”) Region.
Upon signature of the agreement, Formycon will receive an upfront payment and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones. In addition, Formycon will receive a share of the gross profits upon market launch in the region and will be responsible for the manufacturing and supply of the finished product.
“The addition of this important oncology therapeutic to our existing partnership with Lotus underscores our well-established and trusted collaboration and marks another important step in Formycon’s global commercialization strategy. Lotus has a unique footprint in the APAC region. Together we aim to broaden patient access to effective and cost‑efficient treatment options for serious diseases while creating sustainable long-term value”, said Nicola Mikulcik, CBO of Formycon AG.
Petar Vazharov, CEO of Lotus Pharmaceutical, commented: “We are pleased to expand our collaboration with Formycon through this agreement for FYB206, a highly important biosimilar candidate in oncology. Biosimilars represent a key growth pillar for Lotus, and pembrolizumab is among the most clinically impactful and widely used biologics globally. By combining Formycon’s development expertise with Lotus’ strong commercial platform across Asia-Pacific, we aim to improve patient access to high-quality, cost-effective biologic therapies while further strengthening our specialty oncology portfolio in the region.”
FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon and Lotus will closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.
Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 31.7 billion in 20252, Keytruda® is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world. According to market research estimates, sales in the Asia-Pacific region could amount to approximately $7.0 billion in 20253.
1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
2 https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/
3 https://www.grandviewresearch.com/horizon/outlook/keytruda-market/asia-pacific
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Lotus
Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on novel and generic drugs, providing better, safer, and more accessible medicines. With a top-tier R&D and manufacturing platform in Asia, Lotus has partnerships in major markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in Asia and the US, with a portfolio exceeding 250 commercial products. Lotus invests in a diverse portfolio of high-barrier oncology treatments, complex generics, 505(b)(2), and NCE drugs through internal R&D and licensing. It also strengthens its competitiveness with biosimilars, supported by strategic partners. Its infrastructure is certified by leading regulatory authorities, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Further information can be found at https://www.lotuspharm.com/
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner
- FDA approves Biologics License Application (BLA) for additional ranibizumab biosimilar under the trade name Nufymco®
- Zydus becomes commercialization partner for Nufymco® in the US
- Targeted strategy to maximize market penetration for ranibizumab biosimilars by building further on existing partnerships
Planegg-Martinsried, Germany – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1 (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®2. With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.
Zydus Lifesciences Limited (including its subsidiaries and affiliates; “Zydus”) has been secured as another strong commercialization partner for the US market. The company has proven expertise with medically administered drugs (known as Medical Part B), a category that includes Nufymco®. Recently, Zydus also obtained exclusive rights to Formycon’s Keytruda®3 biosimilar FYB206 for the US and Canada – a strong testament to the attractiveness of and confidence in Formycon’s development platform.
Nufymco® is an interchangeable biosimilar to Lucentis®, developed by Formycon, and will be available in the US for all approved indications, expanding access to essential retinal therapies by offering a more affordable treatment option for patients.
“Our FDA approval for Nufymco® marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development. With two strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration,” comments Dr. Stefan Glombitza, CEO of Formycon AG.
Nufymco® is FDA approved for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
1) Nufymco® is a registered trademark of Formycon AG
2) Lucentis® is a registered trademark of Genentech, Inc.
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses, and markets biosimilars. www.bioeq.ch
About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada
- Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206
- Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellence
- Agreement structure includes in total mid-teens-million-euro upfront and 2025 milestone payments, alongside additional development and regulatory milestones and a mid-double-digit-gross-profit-share upon launch
- Clinical development phase of FYB206 nearly completed; primary endpoint data expected in the first quarter of 2026
Planegg-Martinsried, Germany; Ahmedabad, India – Formycon AG (FSE: FYB, “Formycon”) and Zydus Lifesciences Limited (including its subsidiaries and affiliates, “Zydus”), today jointly announced that they have entered into a strategic partnership for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab), in the U.S. and Canada.
Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada. Meanwhile, FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon will prepare the dossier and submit the biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) in due course.
Dr. Stefan Glombitza, CEO of Formycon, commented: “Partnering with Zydus for the U.S. and Canada marks an important milestone for us. Zydus is an established, high-revenue player with a compelling and forward-looking oncology strategy. It has a strong commercial footprint in the U.S., where it generates nearly half of its global revenue and maintains a robust, scalable presence across key commercial channels. By commercializing over 225 FDA-approved products, including injectables and hospital-use medicines, Zydus has shown solid execution strength in complex launches, supporting the high-quality implementation of FYB206. With a streamlined clinical development program, Formycon has secured a leading role among the developers of a pembrolizumab biosimilar and Zydus´ decision to join forces with us underscores their strong confidence in our expertise in developing complex biosimilar medicines for highly regulated countries. Continuing our indicated partnering approach, we are teaming up with strong local partners at attractive commercial terms as we work together to deliver meaningful value for patients and healthcare systems.”
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated: “We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda® across U.S. and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care.”
Upon signature of the agreement, Formycon will be eligible to receive mid-teens-million-euro upfront and milestone payments in 2025. In addition, Formycon will be eligible for further payments linked to the achievement of defined development and regulatory milestones, which in total are expected to amount to a mid–double-digit-million-euro range. Upon market launch, Formycon will obtain a mid–double-digit-share of the gross profits generated in the territory.
Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 20242, Keytruda® is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world.
1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.
2) https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/ Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
Formycon and MS Pharma sign exclusive commercialization partnership for Keytruda® biosimilar candidate FYB206 for the MENA Region
Planegg-Martinsried, Germany / Amman, Jordan – Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon’s biosimilar candidate to the blockbuster drug Keytruda®1 (pembrolizumab), in the Middle East and North Africa (“MENA region”). The agreement includes an option for future technology transfer.
“This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda® biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026”, said Nicola Mikulcik, CBO of Formycon AG.
“Extending our partnership with Formycon for FYB206 (pembrolizumab), is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon’s scientific expertise and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region”, commented Kalle Känd, CEO of MS Pharma.
Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, which are expected to total up to the high single-digit million Euro range. Formycon will further receive a significant share of the gross profits generated in the region.
Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 20242, Keytruda® is currently one of the world’s best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million, positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA3.
1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
2 https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com
3 IQVIA tender data, YTD June 2025.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About MS Pharma:
MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia – home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries. For more information, please visit: www.mspharma.com
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
NTC becomes commercialization partner for Formycon’s Eylea® biosimilar FYB203/Baiama® in Italy
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and NTC s.r.l. (“NTC”) jointly announce that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea®1 biosimilar FYB203 (aflibercept), concluded an exclusive agreement with NTC for the commercialization of FYB203/Baiama®2 in Italy.
As part of the agreement, Klinge is eligible to receive royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.
Nicola Mikulcik, CBO of Formycon AG commented: „Age-related diseases such as wet macular degeneration (“nAMD”) are on the rise in Europe due to the continuously increasing number of people over the age of 65. Our Eylea® biosimilar FYB203 provides ophthalmologists with a safe, effective and cost-efficient treatment option for such serious conditions. For Italy, we are very pleased to present NTC as our partner for the exclusive distribution of FYB203/Baiama®. NTC is a local specialist in ophthalmology with a deep understanding of the specific market landscape and a strong customer network.“
NTC is a leading R&D driven pharmaceutical company based in Italy with a strong focus on disease areas like ophthalmology, gastroenterology, pediatrics, and gynecology. The company’s growing portfolio consists of brand RX products, generic and biosimilar drugs, nutraceuticals and medical devices.
In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE®3 and Baiama® followed in January 2025. One month later FYB203 also received marketing authorization by the British MHRA.4
Eylea® (aflibercept) is used to treat nAMD and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina.
1 Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2 Baiama® is a registered trademark of Klinge Biopharma GmbH
3 AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4 The commercial launch of FYB203 in Europe depends on the progress and outcome of ongoing or potential future patent litigation or possible settlement agreements.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About NTC:
NTC is a pharmaceutical company based in Milan, with products available in over 100 countries through a network of distributors and partners. NTC is engaged in the research, development, registration and marketing of drugs, medical devices and food supplements in the field of ophthalmology, as well as in other therapeutic areas such as pediatrics, gynecology and gastroenterology.
NTC offers more than 250 partners innovative pharmaceutical products of the highest quality standards. Further information at www.ntcpharma.com
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
Ranibizumab Biosimilar Epruvy® launched in Germany
- Sandoz commercializes Epruvy®1 in innovative pre-filled syringe (PFS) and vial presentation in Germany under license from Bioeq AG
- The PFS delivery system represents a key advancement combining biosimilar development excellence with customer-friendly design and expertise in polymer engineering
- Epruvy® expands therapeutic options and broadens patient access to ranibizumab biosimilars in Germany
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and Bioeq AG (“Bioeq”) jointly announce an agreement with Sandoz AG (“Sandoz”) for the commercialization of Epruvy® in Germany. The Lucentis®2 biosimilar Epruvy® (“ranibizumab”) is used to treat severe visual impairments such as neovascular (“wet”) age-related macular degeneration (“nAMD”) and other retinopathies. It is marketed by Sandoz in Germany under a license from Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.
Approved by the European Medicines Agency EMA in September 2024, Epruvy® is available in a vial presentation and, in addition, as a pre-filled syringe, providing patients and healthcare professionals in Germany with a convenient and efficient treatment option.
The innovative PFS technology has been specifically designed for intravitreal injections using a silicone-free device. The system addresses key safety aspects of this delicate ocular treatment, such as the elimination of silicone-oil related contamination, high dosing accuracy, combined with low injection pressure, which can minimize the risk of application errors.
The ready-to-use syringe reduces preparation time and supports efficient administration to patients with nAMD and other serious retinal diseases.
Nicola Mikulcik, CBO of Formycon, comments: “This first-of-its kind ophthalmic biosimilar presentation in Germany marks an important step in unlocking the full commercial potential of our Lucentis® biosimilars. With Sandoz as commercialization partner, we are ideally positioned to further expand market penetration and ensure that even more healthcare professionals and patients in Germany benefit from improved access to high-quality ophthalmic care. This new presentation streamlines clinical workflows and enhances safe usability, making it a compelling choice for ophthalmologists in daily practice. We are confident that this new product will accelerate adoption and strengthen our joint footprint in Europe’s most important healthcare markets.”
1 Epruvy® is a registered trademark of Sandoz AG.
2 Lucentis® is a registered trademark of Genentech Inc.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.
Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch
About Sandoz:
Sandoz is a global leader in generics and biosimilars. Our goal is to improve access to healthcare for patients by developing and marketing innovative, affordable solutions that address unmet medical needs. With our broad portfolio of high-quality medicines covering all major therapeutic areas, we achieved sales of USD 10.4 billion in 2024. Sandoz Germany is headquartered in Holzkirchen, in the greater Munich area.
In Germany, Sandoz markets its broad portfolio through the established brands HEXAL® and 1 A Pharma®. HEXAL® stands for modern drug supply for patients in Germany, from well-known OTC products such as ACC® akut, Lorano® akut, and Gingium® to innovative, biotechnologically manufactured drugs. In this way, we make an important contribution to the sustainable care of patients.
For over 25 years, 1 A Pharma® has been offering high-quality and affordable medicines under the principal “Simply understand.” The brand stands for consistent customer orientation, clear communication, and a focus on what really matters to physicians, pharmacists, and patients.
This and other media information can be found at www.sandoz.de
About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
