Archives Press Releases

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius announce the commercial availability of Otulfi^®1, a biosimilar to Stelara^®2 in the United States (U.S.) and the European Union (EU).

In the U.S., Otulfi^® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The FDA has provisionally determined that Otulfi^® will be interchangeable with the reference drug Stelara^®, following the expiration of a competitor’s interchangeability exclusivity. In the EU, Otulfi^® has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis.

In February 2023, Formycon and Fresenius had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202/Otulfi^® in key global markets, including the U.S. and the EU.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the launch of Otulfi^® in these key global markets, patients, healthcare professionals and payors will have access to a biosimilar with the same efficacy and safety as Stelara^® but at a lower cost. For many patients worldwide suffering from chronic inflammatory diseases, biologic therapies are inaccessible, and many patients experience significant delays before they can benefit from this highly effective treatment. The launch of Otulfi ^® will provide enhanced treatment access and choice.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The U.S. availability of Otulfi^® demonstrates our commitment to serving patients and clinicians and through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S. In addition to approving Otulfi^® for all indications matching the reference product Stelara^®, the FDA also granted a provisional determination of interchangeability for Otulfi^®.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. Otulfi^® was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2024, having successfully met the agency’s standards for biosimilarity to the reference product, including equivalent efficacy, safety and pharmacokinetics.

Otulfi^® will be available in the U.S. and in the European Union in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

Otulfi^® in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA and EMA approval in the first half of 2025.

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¹⁾ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea^®1, under the brand name AHZANTIVE^®2. The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

“With the approval of FYB203, our second ophthalmic biosimilar in the UK, we take yet another significant step in making essential ophthalmic therapies more widely available,” said Dr. Stefan Glombitza, CEO of Formycon AG. “In addition to Ongavia^®3, our successful ranibizumab biosimilar in the UK, ­­AHZANTIVE^® will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva.”

The U.S. Food and Drug Administration (FDA) had already granted marketing authorization for FYB203 in June 2024, followed by European Commission`s approval in January 2025.

Recently, Formycon and Teva Pharmaceuticals International GmbH (Teva) announced a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the United Kingdom, and Israel. Concurrently, Formycon had concluded an agreement with Teva for product supply. Teva is already marketing Formycon’s FYB201 ranibizumab Biosimilar (Ongavia^®) in the UK and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field.

Aflibercept is an inhibitor of the vascular endothelial growth factor (VEGF), which plays a key role in the abnormal formation of blood vessels in the retina, leading to vision impairment.

¹⁾ Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾ AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
³⁾ Ongavia^® is a registered trademark of Teva Pharmaceuticals Limited

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) will present an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year’s Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place in Berlin, Germany, from February 19 to 22, 2025. The poster presentation summarizes the clinical phase I and phase III study results and is complemented by advanced analytical laboratory data demonstrating the comparability of FYB202 with the reference product Stelara^®1.

Using a comprehensive set of analytical methods, the relevant quality characteristics of FYB202 were first examined and its functional comparability with the reference product was assessed in terms of the main mechanism of action using IL-12 and IL-23 binding tests and bioassays. FYB202 was found to be analytically comparable to the reference ustekinumab with respect to physicochemical and biological properties, including structure, function, purity and potency.

The therapeutic equivalence of FYB202 was demonstrated in a Phase I pharmacokinetics (PK) study in 491 healthy volunteers and in a Phase III efficacy study in 392 patients with moderate to severe plaque psoriasis. Based on a totality of evidence approach, these results allow for extrapolation to other approved indications of the reference drug and confirm that FYB202 has a comparable clinical performance to Stelara^® in all indications, making it a safe and highly effective alternative for patients treated with ustekinumab.

Presentation details:

• Session: Guided poster session, February 21, 2025, 12:40 pm – 1:40 pm CET
• Poster-ID: P0879
• Title: The Totality of Evidence for FYB202 – an EU-approved and US-licensed Biosimilar to Reference Ustekinumab
• Room: Poster Exhibition Area
• Date: February 19-22, 2025

FYB202 is an interleukin inhibitor that can be used in dermatology to treat psoriasis and in gastroenterology to treat chronic inflammatory bowel disease. The biosimilar received marketing authorization from the EMA and the FDA in September 2024, and from Health Canada and the UK’s MHRA in January 2025.

1) Stelara^® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) (“Formycon” or “the Company”) today provided an update on key developments across various biosimilar projects and invites participants to an extraordinary conference call on February 17, 2025, at 5:00 p.m. CET to share further details regarding these recent events.

FYB206 – biosimilar to Keytruda^®3 (pembrolizumab)

Based on intensive scientific dialogue with the U.S. Food and Drug Administration (FDA) regarding the clinical development programme, the Executive Board of Formycon has today decided to terminate the phase III trial (“Lotus”) for the biosimilar candidate FYB206 ahead of schedule. After careful consideration, the Executive Board has concluded that the continuation of the trial is no longer necessary for the development and approval of FYB206 in the U.S. The therapeutic comparability of FYB206 with the reference drug Keytruda^® can be sufficiently demonstrated based on the comprehensive analytical data and the data from the parallel phase I trial (“Dahlia”) in patients with malignant melanoma (black skin cancer). Formycon is thus taking a pioneering role among pembrolizumab biosimilar developers, once again highlighting its expertise in the development of biosimilars. Patients with non-small cell lung cancer (NSCLC) who have been treated in the phase III trial so far will continue to be given the reference drug Keytruda^®.

As a result of the early termination of the extensive phase III trial, the company expects probable investment savings in the high double-digit millions over the next few years. As the development costs for FYB206 have been capitalised on the balance sheet since 2022, future savings will not affect the income statement but will have a direct positive impact on liquidity. Accordingly, the company expects significantly positive effects in the high double-digit million range for the cash flow statement and working capital.

FYB202/Otulfi^TM – biosimilar to Stelara^®4 (ustekinumab)

In consultation with its commercialization partner Fresenius Kabi AG in the context of the imminent market launch of FYB202/Otulfi^TM in the U.S., Formycon assumes that the valuation model and the balance sheet measurement for FYB202 will need to be reviewed and adjusted accordingly due to an emerging, significantly higher-than-expected price discount for biosimilars in the U.S. In 2022, FYB202 was acquired by the Company through a contribution in kind as part of the Athos transaction and approved in 2024 in the U.S. and Europe in various immunological indications. According to preliminary calculations, Formycon currently expects a non-cash impairment in the high double-digit to almost low triple-digit million range. The exact figures are currently being calculated and audited by the company as part of the year-end financial audit.

FYB201/CIMERLI^® – biosimilar to Lucentis^®5 (ranibizumab)

Due to the increasing price discount offered by ranibizumab providers in the US, Bioeq AG, the exclusive license holder of FYB201/CIMERLI^®, is currently in discussions with its commercialization partner Sandoz AG regarding the further commercialization strategy for FYB201/CIMERLI^® in the U.S. Based on the status of these discussions, the company currently assumes that the commercialization of FYB201/CIMERLI^® will likely be temporarily paused. As a result, this is expected to lead to an extraordinary adjustment of the valuation model and the balance sheet measurement for FYB201 as well as the stake in Bioeq AG, amounting to a high single-digit to low double-digit million figure for the 2024 financial year. In this context, Bioeq AG is evaluating alternative commercialization strategies for the ophthalmic biosimilar in the U.S. Formycon will provide updates on further developments in due course.

The Company currently assumes that the key financial performance indicators (Group revenue and EBITDA, adjusted Group EBITDA and working capital) for the 2024 financial year should not be affected by these adjustments. However, the company’s net result could be negatively affected by the impairment.

Dr Stefan Glombitza, CEO of Formycon AG, commented: “The latest developments in our projects underscore both the dynamics and the opportunities of the market environment. For biosimilars in the so-called Pharma Benefit market segment in the US, it is becoming apparent that the market opening for biosimilars is still progressing slower and requires greater price discounts than previously anticipated. This will also affect our product FYB202/Otulfi^TM, which is marketed by our partner Fresenius Kabi. In the case of FYB201/CIMERLI^®, our partner Sandoz is observing increasing price discounts in the U.S. and has informed us of planned adjustments to the marketing strategy. Bioeq AG is therefore examining options for alternative commercialization strategies for the U.S. that combine economic success with long-term market presence. Biosimilars have already amply demonstrated that they can achieve a sustainable market position in the long term and are based on a profitable business model. Our strategy remains focused on working with our partners to achieve a leading position in this dynamic environment.

At the same time, regulatory developments in the U.S. indicate that the framework conditions for biosimilars continue to improve. The FDA has confirmed that extensive analytical data, together with the ongoing phase I trial, will be sufficient to demonstrate the therapeutic comparability of our biosimilar candidate FYB206 with Keytruda^®. This eliminates the need for a phase III trial for FYB206 – an important step that will not only shorten the development time but also significantly reduce investment. This also highlights the importance of the quality of our analytical and preclinical data. Formycon is thus taking on a pioneering and leading role among Keytruda^® biosimilar developers.”

Enno Spillner, CFO of Formycon AG, added: “We expect the financial adjustments in our three projects to have differing effects. The consideration of the price discounts for FYB202 will require a review of our assumptions and financial models. This could lead to significant valuation adjustments for FYB202. In addition, the temporally pause in the marketing of FYB201 would require an adjustment to our short-term planning. Therefore, we are currently analyzing the potential impact and the specific impairment requirements. Meanwhile, the decision on FYB206, based on feedback from the FDA, brings us significant financial benefits. By ending the phase III trial early, we expect savings in the high double-digit million range over the next few years. This strengthens our working capital, creates additional financial flexibility for the further development of our pipeline and could partially compensate for lower cash flows from FYB201 and FYB202. We will provide guidance for the 2025 financial year when publishing the 2024 annual financial statements. In general, our goal of achieving profitability and positive operating cash flow in the medium term remains unchanged.”

Conference call and webcast

The Executive Board of Formycon AG will discuss and provide context for the company’s latest developments in a conference call. The conference call, which will be webcast live, will be held in English on February 17, 2025, at 5:00 p.m. (CET).

To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/X9bNqTxsvSRH

After registration, participants will receive a confirmation email with individual dial-in details and the date.

The presentation and audio broadcast can be accessed via the following webcast link: https://www.webcast-eqs.com/formycon-2025-02

After a short presentation, the Executive Board will be available to answer analysts’ questions. The webcast will be recorded and will be available for viewing afterwards on the Formycon website at: https://www.formycon.com/news-media/blog/.

1) Otulfi^TM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.
3) Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) Stelara^® is a registered trademark of Johnson & Johnson
5) Lucentis® is a registered trademark of Genentech, Inc.

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE^®1 (aflibercept), Formycon’s biosimilar to Eylea^®2, informed Formycon AG (FSE: FYB), that it has concluded an exclusive license agreement with Lotus Pharmaceutical (“Lotus”), a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE^® in Asia-Pacific (“APAC”) countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong. In parallel, Formycon has signed an agreement with Lotus under which Formycon will supply the finished product.

Lotus is a global pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines. Upon signature of the agreement, Klinge will receive upfront payments and is eligible to receive milestone payments on launch and sales. Additionally, Klinge will receive royalties on Lotus’ net sales. Formycon will participate in all Klinge income in the mid-single to low-double-digit percentage range.

“We are extremely pleased to welcome Lotus as a strong partner with a unique presence in the APAC region. Formycon and Lotus share the ambition to improve access to affordable, high-quality medicines for patients worldwide. Together we look forward to making a relevant contribution to healthcare in the APAC region and providing AHZANTIVE^® as an effective and cost-efficient treatment option for patients affected by serious retinal diseases,” says Nicola Mikulcik, CBO of Formycon AG.

“Lotus is proud to partner with Formycon and to add AHZANTIVE^® (aflibercept), a biosimilar to Eylea^®, to our product portfolio aimed at improving access to healthcare in the Asia-Pacific region,” says Petar Vazharov, CEO of Lotus. “Leveraging our regional expertise, we look forward to working closely with Formycon to deliver this impactful and much-needed treatment to healthcare providers and patients.”

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. Approval by the European Commission followed in January 2025. Formycon and Lotus closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (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) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea^®1, under the brand names AHZANTIVE^®2 and Baiama^®3. The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The EU approval of FYB203, our biosimilar for Eylea^®, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE^® and Baiama^®, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.”

Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, thereby impairing vision. In 2023, the reference product Eylea^® achieved global sales of approximately USD 9 billion⁴, highlighting the significance and necessity of a cost-effective alternative like FYB203.

In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024.

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
⁴⁾ Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi^®1 (ustekinumab), a biosimilar to Stelara^®2, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “For millions of people around the world, chronic inflammatory diseases have a massive impact on the quality of life. There is a clear demand to help those patients, who are suffering severely from the symptoms of their disease. Each approval is important and brings us a step ahead in our mission to offer a highly effective and cost-efficient treatment option to as many patients as possible across multiple geographies.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

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¹⁾ Otulfi^® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (Klinge), the licensee and exclusive global commercialization rights holder for FYB203, Formycon’s biosimilar candidate to Eylea^®1 (Aflibercept), informed Formycon AG (FSE: FYB) about the signing of a licensing agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (Teva) for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel. In parallel Formycon has signed an agreement with Teva under which Formycon will supply the finished product.

The collaboration combines Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries with Teva’s deep commercial experience in biosimilars and its extensive distribution network and -broad sales and marketing reach across Europe.

Teva is a global pharmaceutical leader harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine.

Under the licensing agreement, Teva will obtain semi-exclusive commercialization rights for major parts of Europe, excluding Italy, as well as for Israel for FYB203, Formycon’s biosimilar candidate to Eylea^®, to be marketed under the brand name AHZANTIVE^®2 subject to regulatory approval. In return, Klinge will receive milestone payments and royalties on net sales.

Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from this agreement. Furthermore, Formycon will receive payments for organizing the commercial market supply of AHZANTIVE^® on behalf of Klinge.

“With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio^®3/ Ongavia^®4) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product,” commented Nicola Mikulcik, CBO of Formycon AG.

Commenting on the agreement, Richard Daniell, Executive Vice President European Commercial of Teva, says: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio^®3 / Ongavia^®4) for Lucentis^®5 in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve.”

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE^® / Baiama^®4. The European Commission’s decision on approval is expected in the second half of January 2025.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (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. In 2023, Eylea^® achieved global sales of approximately USD 9 billion[i], including USD 2.9 billion[ii] in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.

1 Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
2 AHZANTIVE^®is a registered trademark of Klinge Biopharma GmbH
3 Ranivisio^® is a registered trademark of Bioeq AG
4 Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
5 Lucentis^® is a registered trademark of Genentech Inc.
6 Baiama^®is a registered trademark of Klinge Biopharma GmbH

[i] https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

[ii] IQVIA sales data

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) will officially be included in the TecDAX of Deutsche Börse on January 13, 2025. This decision was announced today as part of an unscheduled index adjustment by Deutsche Börse. With its inclusion in the TecDAX, Formycon is now ranked among the 30 largest publicly traded technology companies in Germany, based on free-float market capitalization and trading volume.

“We are extremely pleased that, just three weeks after joining the SDAX, Formycon will now also be included in the TecDAX. This milestone strengthens our position in the capital markets and increases our visibility as one of Germany’s important technology stocks. Being part of these important stock indices underscores the success of our capital market strategy. Moreover, it serves as further recognition of the outstanding performance of the entire Formycon team as part of our successful growth strategy as a leading ‘pure-play’ biosimilar developer,” said Enno Spillner, CFO of Formycon AG.

Since its initial listing in 2010, Formycon has consistently aligned itself with the demands of the capital markets, thereby laying the foundation for its exceptionally positive business development in recent years. This strategic focus also paved the way for the successful uplisting to the Prime Standard of Deutsche Börse in November 2024.