Strong demand for Formycon 2025/2029 Bond leads to early closing of subscription period

  • High demand by institutional investors enables early termination of public offering period
  • Subscription period via the Formycon website is now scheduled to end on 26 June 2025, at 11:59 p.m. CEST
  • Subscription via Deutsche Börse’s DirectPlace still possible until 27 June 2025, at 12:00 p.m. CEST
  • Inclusion to trading on the Frankfurt Stock Exchange in the Quotation Board segment is still scheduled for 9 July 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announced that strong demand, particularly from institutional investors, for its 2025/2029 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) has led to the public offering period ending ahead of schedule.

Interested investors may submit their binding subscription offers until 26 June 2025, 11:59 p.m. CEST via the company’s website (https://www.formycon.com/en/investor-relations/bond-2025/) and until 27 June 2025, 12:00 p.m. CEST via Deutsche Börse’s subscription functionality ‘DirectPlace”.

“The strong demand for our inaugural bond issuance is a clear sign of Formycon’s capital markets maturity and the trust in our sustainable business model,” said Enno Spillner, CFO of Formycon AG. “The significant interest, particularly from institutional investors, validates our strategic direction and financial strength. The bond will enhance our financial flexibility and represents an important milestone in the long-term diversification of our capital structure and investor base.”

The bond carries a variable interest rate consisting of the three-month EURIBOR plus a margin ranging from 7.0% to 7.5% per annum. The final margin will be determined on 27 June 2025, based on all submitted subscription offers. Listing on the Quotation Board (Open Market) of the Frankfurt Stock Exchange is still scheduled for 9 July 2025, but the company reserves the right to allow trading upon publication in advance. Formycon plans to apply for the bond to be admitted to trading on Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following the issuance.

The supplement to the securities prospectus approved by the Luxembourg Commission de Surveillance du Secteur Financier (CSSF), Luxembourg, and to be notified to the Federal Financial Supervisory Authority (Bundesanstalt für Finanzdiensteistungsaufsicht – BaFin), Germany, and the Austrian Financial Market Authority (Österreichische Finanzmarktaufsichtsbehörde – FMA) will be published on the website of the Luxembourg Stock Exchange (www.luxse.com) and the Company (https://www.formycon.com/en/investor-relations/bond-2025/).

Key Terms of the Formycon Corporate Bond 2025/2029

IssuerFormycon AG, Planegg-Martinsried, Germany
Issuer Volume (Target)EUR 50,000,000
ISIN / WKNNO0013586024 / A4DFJH
Interest Rate Range3-months EURIBOR plus 7.0 % to 7.5 % p.a.
Issue Price100 %
DenominationEUR 1,000
Interest PaymentQuarterly, first payment on October 9, 2025
TermFour years, July 9, 2025 to July 9, 2029
Redemption DateDue on July 9, 2029
StatusSenior unsecured
CovenantsIncludes restrictions on distributions, liquidity maintenance, and quarterly financial reporting
Stock Exchange SegmentOpen Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months
Issue / Value DateJuly 9, 2025
Joint Lead ManagerIKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch


Early end of the offer period for the bond due to high demand

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014


NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION OR PUBLICATION MAY BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE REFER TO THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

Planegg-Martinsried, Germany, 24 June 2025 – The announced corporate bond (ISIN NO0013586024 / WKN A4DFJH) (“Bond“) of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) (“Company“) has met with great interest, particularly among institutional investors.

Due to the strong demand, the offer period of the public offer of the Bond will be shortened. Interested investors can still submit their binding offers to purchase bonds via the Company’s website (https://www.formycon.com/en/investor-relations/bond-2025/) until 26 June 2025, 23:59 CEST, and via the subscription functionality DirectPlace of Deutsche Börse until 27 June 2025, 12:00 CEST.

Inclusion to trading on the Frankfurt Stock Exchange in the Quotation Board segment (Open Market) is still scheduled for Wednesday, 9 July 2025. The company reserves the right to enable trading upon publication in advance.

The supplement to the securities prospectus approved by the Luxembourg Commission de Surveillance du Secteur Financier (CSSF), Luxembourg, and to be notified to the Federal Financial Supervisory Authority (Bundesanstalt für Finanzdiensteistungsaufsicht – BaFin), Germany, and the Austrian Financial Market Authority (Österreichische Finanzmarktaufsichtsbehörde – FMA) will be published on the website of the Luxembourg Stock Exchange (www.luxse.com) and the Company (https://www.formycon.com/en/investor-relations/bond-2025/).


Formycon bond 2025/2029: Public subscription now also possible via Deutsche Börse

  • The subscription period via Deutsche Börse AG’s DirectPlace is now open and will close on 30 June 2025 at 12:00 p.m. CEST (subject to early closure)
  • The unsecured senior bond has a target volume of €50 million and carries a variable interest rate of EURIBOR plus a margin between 7.0% and 7.5% p.a.
  • With this bond, Formycon is strengthening its financial flexibility for the next growth phase

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that investors can now subscribe to the 2025/29 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) via Deutsche Börse’s ‘DirectPlace’ subscription service. This service allows interested investors to place purchase orders directly with their house bank or custodian bank on the Frankfurt Stock Exchange during the subscription period. Since June 17, 2025, it is also possible to subscribe to the bond directly via the company website at (https://www.formycon.com/en/investor-relations/bond-2025/). The company intends to use the proceeds to advance its growth strategy – in particular for the consequent development and expansion of the Company’s biosimilar product portfolio.

“With this bond, we are opening ourselves up to a broader investor base and are utilizing the bond market as a strategic capital market instrument for the first time. This gives us the flexibility to further develop our pipeline and strengthen our position as a growth-oriented company with an increasing commercial focus,” explains Enno Spillner, CFO of Formycon AG.

The bond governed by Norwegian law, is intended to be included in the Open Market (Freiverkehr) of the Frankfurt Stock Exchange. Additionally, the Company intends to apply for the bond to be admitted to trading on Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following issuance.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bonds are being issued as part of a public offering in Luxembourg, Germany and Austria. The offering is based on a securities prospectus approved by CSSF, which has been notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus is available on the websites of the Luxembourg Stock Exchange (www.luxse.com) and Formycon AG (https://www.formycon.com/en/investor-relations/bond-2025/).

In addition, the Joint Lead Managers plan to offer the bond to institutional investors in Germany, Luxembourg, and Austria, as well as selected other European and international markets as part of a private placement.

Key Terms of the Formycon Corporate Bond 2025/2029

IssuerFormycon AG, Planegg-Martinsried, Germany
Issuer Volume (Target)EUR 50,000,000
ISIN / WKNNO0013586024 / A4DFJH
Interest Rate Range3-months EURIBOR plus 7.0 % to 7.5 % p.a.
Issue Price100 %
DenominationEUR 1,000
Interest PaymentQuarterly, first payment on October 9, 2025
TermFour years, July 9, 2025 to July 9, 2029
Redemption DateDue on July 9, 2029
StatusSenior unsecured
CovenantsIncludes restrictions on distributions, liquidity maintenance, and quarterly financial reporting
Stock Exchange SegmentOpen Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months
Issue / Value DateJuly 9, 2025
Joint Lead ManagerIKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch


Ordinary Annual General Meeting of Formycon AG approves all proposed resolutions by large majorities

  • Management provides detailed report on financial year 2024 and provides outlook for 2025
  • Supervisory Board expands to six members; Klaus Röhrig re-elected
  • Graham Keith Dixon elected as a new member of the Supervisory Board

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) held its Annual General Meeting on 18 June 2025 as an in-person event in Munich. In its presentation, the Management Board provided shareholders with a detailed report on the company’s development and answered all questions in the general debate.

In its report to the Annual General Meeting, the Management Board highlighted Formycon’s strong operational performance in the 2024 fiscal year and provided a detailed outlook for the ongoing year 2025. The company has successfully evolved in recent years from a purely development-focused organization into a commercially oriented biosimilar company with a steadily expanding and maturing product portfolio. Increasing revenues from global licensing and commercialization partnerships now provide a robust foundation for implementing the company’s growth strategy. The Management Board reaffirmed its commitment to maintaining this positive momentum, unlocking new market opportunities, and further expanding Formycon’s international presence.

The represented shareholders followed the proposals of the Management Board and Supervisory Board and approved all of the Executive Board’s proposed resolution resolutions with large majorities. Both the members of the Management Board and the Supervisory Board were given a formal approval of their actions with majorities of over 97 per cent in each case.

The resolution to expand the Supervisory Board from five to six members was passed to meet the growing requirements for the Board following the Company’s listing in the Prime Standard. Klaus Röhrig, Co-Chief Investment Officer of Active Ownership Capital S.à r.l. and Active Ownership Corporation S.à r.l., whose term of office as a member of the Supervisory Board ended automatically at the end of the Annual General Meeting on 18 June 2025, was re-elected as member of the Supervisory Board by a large majority. To further strengthen the Supervisory Board’s international focus and expertise, Dr. Graham Keith Dixon, Chief Executive Officer (CEO) of Estetra SRL, a subsidiary of Gedeon Richter Plc., was also elected to the expanded Supervisory Board by a large majority.

Wolfgang Essler, chief representative of the main shareholder ATHOS KG and Chairman of the Supervisory Board of Formycon AG, commented: “On behalf of the Supervisory Board of Formycon AG, I would like to congratulate Klaus on his re-election and Graham on his election. We look forward to their contributions and perspectives as we continue our close and constructive collaboration with the Formycon Management Board. The growing importance of biosimilars in global healthcare markets underscores Formycon’s strategic focus, positioning it as a leader in biosimilar development and delivering long-term value for patients and shareholders alike.”

Votes were cast for 67.06 percent of the share capital. The detailed voting results and further information on the 2025 Annual General Meeting can be found at Annual General Meeting 2025 – Formycon AG


Subscription period for 2025/2029 corporate bond has started

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that the securities prospectus for the newly issued corporate bond 2025/2029 (ISIN NO0013586024 / WKN A4DFJH) has been approved by the Luxembourg financial supervisory authority (CSSF) on June 17, 2025, and that investors can now subscribe to the bond via the company’s website. The newly issued four-year unsecured senior bond has a target volume of EUR 50 million and carries a variable interest rate.

The Management and Supervisory Boards of Formycon AG approved the new bond issuance on June 17, 2025. The proceeds will be used to advance Formycon’s growth strategy – in particular for the consequent development and expansion of the Company’s biosimilar product portfolio. The bond has a minimum subscription amount of EUR 1,000, is governed by Norwegian law and carries a variable interest rate consisting of three-month EURIBOR plus a margin between 7.0% and 7.5% p.a. The final margin is expected to be determined and announced on June 30, 2025, based on submitted subscription offers.

Interested investors can submit binding subscription offers during the subscription period either via the company’s website (www.formycon.com; subscription period: June 18 to June 27, 2025, 11:59 p.m. CEST) or via Deutsche Börse’s “DirectPlace” subscription functionality (subscription period: June 20 to June 30, 2025, 12:00 noon CEST), subject to early closing. Using DirectPlace, investors can place buy orders through their custodian bank during the subscription period at the Frankfurt Stock Exchange; alternatively, subscription via the company’s website is available.

The Bond, governed by Norwegian law, is intended to be included in the Open Market (Freiverkehr) of the Frankfurt Stock Exchange. Additionally, the Company intends to apply for the Bond to be admitted to trading on Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following issuance.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bond was issued as part of a public offering in Luxembourg, Germany, and Austria. The offering is based on a securities prospectus approved by CSSF, which has been notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus is available on the websites of the Luxembourg Stock Exchange (www.luxse.com) and Formycon AG (www.formycon.com, section ‘Investor Relations’).

In addition, the Joint Lead Managers plan to offer the bond to institutional investors in Germany, Luxembourg, and Austria, as well as selected other European and international markets as part of a private placement.

With the placement of the bond, Formycon is utilizing this capital market instrument for the first time to further and sustainably strengthen its position as a growth-oriented company with an increasing commercial focus in a highly attractive and dynamically growing market.

Key Terms of the Formycon Corporate Bond 2025/2029

IssuerFormycon AG, Planegg-Martinsried, Germany
Issuer Volume (Target)EUR 50,000,000
ISIN / WKNNO0013586024 / A4DFJH
Interest Rate Range3-months EURIBOR plus 7.0 % to 7.5 % p.a.
Issue Price100 %
DenominationEUR 1,000
Interest PaymentQuarterly, first payment on October 9, 2025
TermFour years, July 9, 2025 to July 9, 2029
Redemption DateDue on July 9, 2029
StatusSenior unsecured
CovenantsIncludes restrictions on distributions, liquidity maintenance, and quarterly financial reporting
Stock Exchange SegmentOpen Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months
Issue / Value DateJuly 9, 2025
Joint Lead ManagerIKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch


Formycon plans public corporate bond issuance to support next growth phase within attractive Biosimilar markets

  • Unsecured bond 2025/2029 with a target volume of EUR 50 million and variable interest rate
  • Proceeds will support the targeted development of biosimilar product portfolio and the execution of the next growth phase
  • Private placement to institutional investors and public offering in selected countries
  • Public subscription available via the Formycon website starting June 18 and via Deutsche Börse’s DirectPlace platform starting June 20

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today decided to issue a four-year corporate bond (ISIN NO0013586024 / WKN A4DFJH) with a target volume of EUR 50 million. The company intends to use the proceeds to advance its growth strategy – in particular for the consequent development and expansion of the Company’s biosimilar product portfolio.

“In recent years, Formycon has evolved from a biosimilar development company into a commercially focused company with a growing and maturing product portfolio while increasing revenues from global licensing and commercialization partnerships. This commercial foundation enables us to tap into another attractive source of financing with the planned bond issuance. It is our goal to transition our corporate financing towards a more long-term setup. In doing so, we are optimizing our capital structure and tapping into debt capital for the first time. The proceeds will support the continued execution of our strong growth strategy, the optimization of our biosimilar platform, and the further strengthening of our position as a commercially operating company. Having laid a solid groundwork with the necessary structures and processes over the past years, we are now ready to scale them to the next success level,” said Enno Spillner, CFO of Formycon AG.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bonds will be issued as part of a public offering in Luxembourg, Germany, and Austria. The offering is based on a securities prospectus which is expected to be approved today by the Luxembourg financial supervisory authority (CSSF) and to be notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus will be published on the websites of the Luxembourg Stock Exchange (www.luxse.com) and Formycon AG (www.formycon.com, section ‘Investor Relations’).

In addition, the Joint Lead Managers plan to offer the bond to institutional investors in Germany, Luxembourg, and Austria, as well as selected other European and international markets as part of a private placement.

Interested investors may submit their binding subscription offers during the offering period either through Deutsche Börse’s subscription functionality “DirectPlace” (subscription period: June 20 to June 30, 2025, 12:00 p.m. CEST) or via the Formycon AG website (www.formycon.com; subscription period: June 18 to June 27, 2025, 11:59 p.m. CEST), subject to an early closing of the subscription period. When using DirectPlace, investors may place purchase orders through their house or custodian bank on the Frankfurt Stock Exchange during the subscription period; alternatively, the subscription is also possible via the website.

The Bond, governed by Norwegian law, will have a term of four years. The minimum investment amount is EUR 1,000. The interest rate will be based on the three-month EURIBOR plus a margin ranging from 7.0% to 7.5% per annum. The final margin and total nominal amount of the Bond are expected to be determined and announced on or around June 30, 2025, based on the subscription offers received.

The Bond is intended to be included in the Open Market (Freiverkehr) of the Frankfurt Stock Exchange. Additionally, the Company intends to apply for the Bond to be admitted to trading on Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following issuance.

With the placement of the bond, Formycon is utilizing this capital market instrument for the first time to further and sustainably strengthen its position as a growth-oriented company with an increasing commercial focus in a highly attractive and dynamically growing market.

Key Terms of the Formycon Corporate Bond 2025/2029

IssuerFormycon AG, Planegg-Martinsried, Germany
Issuer Volume (Target)EUR 50,000,000
ISIN / WKNNO0013586024 / A4DFJH
Interest Rate Range3-months EURIBOR plus 7.0 % to 7.5 % p.a.
Issue Price100 %
DenominationEUR 1,000
Interest PaymentQuarterly, first payment on October 9, 2025
TermFour years, July 9, 2025 to July 9, 2029
Redemption DateDue on July 9, 2029
StatusSenior unsecured
CovenantsIncludes restrictions on distributions, liquidity maintenance, and quarterly financial reporting
Stock Exchange SegmentOpen Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months
Issue / Value DateJuly 9, 2025
Joint Lead ManagerIKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch


Formycon plans to issue a public senior unsecured floating rate bond with target volume of EUR 50 million to support further company growth

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014


NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION OR PUBLICATION MAY BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE REFER TO THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

Planegg-Martinsried, Germany, 17 June 2025 – The Management Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Company”) today resolved, with the approval of the Supervisory Board,  to examine the possibility of issuing a public senior unsecured, floating rate corporate bond with a target volume of EUR 50 million (ISIN: NO0013586024 / WKN: A4DFJH) (the “Bond”) to support its ongoing growth strategy (the “Transaction”). The Transaction is being jointly arranged by IKB Deutsche Industriebank AG and Pareto Securities AS (together, the “Joint Lead Managers”).

The issuance is intended to be carried out as a public offering (“Offering”) in Germany, Luxembourg and Austria based on a securities prospectus (“Prospectus”) which is expected to be approved today by the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) and to be notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The public offering relates to bonds with a total nominal value of up to EUR 50 million. The Prospectus will be published on the websites of the Luxembourg Stock Exchange (www.luxse.com) and the Company (www.formycon.com) under the “Investor Relations” section. In addition to the public offering, the Joint Lead Managers also intend to place the Bond with institutional investors in Germany, Luxembourg and Austria, as well as in selected European and other countries, via a private placement.

The net proceeds will be used to finance the development and expansion of the Company’s biosimilar product portfolio as part of its corporate growth strategy.

Interested investors may submit their binding offers to purchase bonds during the offering period either through Deutsche Börse’s subscription functionality “DirectPlace” (from 20 June to 30 June 2025, 12:00 noon CEST) or via the Company’s website (www.formycon.com; from 18 June to 27 June 2025, 11:59 p.m. CEST), subject to an early closing of the subscription period.

The Bond, governed by Norwegian law, will have a term of four years. The minimum investment amount is EUR 1,000. The interest rate will be based on the three-month EURIBOR plus a margin ranging from 7.0% to 7.5% per annum. The final margin and total nominal amount of the Bond are expected to be determined and communicated on or around 30 June 2025 based on the subscription offers received. The Bond is intended to be included in the Open Market (Freiverkehr) of the Frankfurt Stock Exchange. Additionally, the Company will apply for the Bond to be admitted to trading on the Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following issuance.

The final decision on the Transaction will depend on market conditions and the outcome of discussions with potential investors. The Company will inform the capital markets and the public of any developments in line with legal requirements.


Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil

  • Brazilian regulatory authority ANVISA grants marketing authorization for Ranivisio®
  • Commercialization partnership established with Brazilian pharmaceutical company Biomm
  • Product launch in Brazil expected in Q4 2025, kicking off the commercial rollout of FYB201 across Latin America
  • Further market approvals of FYB201/Ranivisio® granted in Central and South America

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio®1, a biosimilar to Lucentis®2 (ranibizumab). Product launch by the Brazilian biopharma specialist Biomm is expected in Q4 2025, marking the beginning of a phased market rollout of FYB201/Raniviso® across Latin America. Marketing authorizations have already been granted by the regional regulatory authorities in Peru, El Salvador, Honduras, and the Dominican Republic. Further approvals and product launches in Central and South America are planned through early 2027.

“The marketing approval of FYB201/Ranivisio® in Brazil underlines our mission to improve access to high-quality biologic drug therapies especially in countries where the usage of high-cost biologics is quite limited today,” says Formycon CBO Nicola Mikulcik, adding: “We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil. In Biomm, we have a strong commercial partner with in-depth knowledge of the local market and the specific requirements of the ophthalmology sector. Based on the country-by-country rollout in LATAM, which is planned to start in Q4 this year, we expect the region to become a good contributor to our profits mid-term.”

Biomm is a well-established pharmaceutical company with a strong presence in Brazil, the largest healthcare market in South America. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars. According to Biomm, the Brazilian market for anti-VEGF therapies, including the active ingredient ranibizumab, is valued at BRL 374 million (approx. US$ 66 million) annually and has demonstrated consistent growth over the past three years.

FYB201/Ranivisio® (ranibizumab) is used to treat severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, the biosimilar is currently available in a total of 21 countries in Europe, North America and the MENA region.


1Ranivisio® is a registered trademark of Bioeq
2Lucentis® is a registered trademark of Genentech Inc.


Formycon and Fresenius Kabi announce the commercial launch of FYB202/Otulfi™, an approved ustekinumab biosimilar, in Canada

  • FYB202/Otulfi is now commercially available in Canada in both subcutaneous and intravenous formulations
  • Launch expands market presence beyond the U.S. and Europe, offering broader treatment options for patients with chronic autoimmune diseases
  • KabiCare® patient support program ensures seamless transition and ongoing care directly for patients

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi proudly announce the market launch of FYB202/Otulfi1 an ustekinumab biosimilar referencing Stelara®2 in Canada. Following Health Canada’s Notice of Compliance (NOC) end of December 2024, Otulfi is now available as a high-quality and cost-effective treatment option for adult patients with moderate to severe active Crohn’s disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

“Canada is a key market with a strong commitment to biosimilar adoption. We are proud that our ustekinumab biosimilar is now available to Canadian patients, contributing to broader access to high-quality biologic therapies across the North American continent,” said Dr. Stefan Glombitza, CEO of Formycon AG. “For many patients suffering from chronic inflammatory diseases, access to biologic therapies remain limited. There are often substantial delays that keep patients from benefiting from these highly effective treatments when they need them most. Biosimilars like Otulfi play a crucial role in reducing healthcare expenditure while maintaining high standards in quality and safety of patient care.”

To support patients transitioning to Otulfi, Fresenius Kabi provides access to its KabiCare® patient support program. KabiCare® offers a full range of services including injection training, reimbursement assistance, a dedicated single point of contact, bloodwork coordination and lifestyle assessments. With KabiCare®, patients receive assistance in accessing their medicine, ongoing support, education, and guidance throughout their biosimilar treatment journey.

“The high demand for biosimilars in Canada underscores the necessity for accessible and cost-effective biologics. We are very proud to be introducing a cost-effective and European manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases,” said Abhi Bhoite, Sr. Director and Head of Commercial, Fresenius Kabi Biopharma, Canada.

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 and launched in Europe and the U.S. in March 2025.

Otulfi is available in Canada in the following presentations:

  • 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for subcutaneous injection
  • 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

 

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


Formycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi® (ustekinumab-aauz)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce today that the U.S. Food and Drug Administration (FDA) designated FYB202/Otulfi®1 (ustekinumab-aauz) as interchangeable with the reference biologic Stelara®2 (ustekinumab). As of April 30, 2025, Otulfi® is interchangeable in all presentations matching the reference product.

Fresenius Kabi launched the 45 mg and 90 mg single-dose prefilled syringe for injection as well as the 130 mg single dose vial presentations for IV infusion in the U.S. beginning of March 2025. In April the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code (Q-Code) for Otulfi®. These codes are used by commercial insurers and government payers to standardize claims submissions and simplify reimbursements.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The interchangeability designation for FYB202/Otulfi® in the U.S. is a strong endorsement of the product’s excellent quality and underscores Formycon’s recognition as one of the leading biosimilar developers. Both the product-specific reimbursement code and the interchangeability designation are important drivers of improved patient access to a much-needed treatment option for severe inflammatory diseases in the U.S. This will create additional impetus for market uptake.”

Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status.

FYB202/Otulfi® was approved by the U.S. Food and Drug Administration (FDA) in September 2024 for the treatment of the same conditions as Stelara®. FDA approval and interchangeability designation are based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/Otulfi® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug in patients with moderate to severe plaque psoriasis and offers a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.


 

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