EQS-News: Teva becomes secondary commercialization partner for Formycon's Stelara® biosimilar FYB202 (ustekinumab) under the brand name Fymskina® in Germany

Press Release // June 26, 2025

Teva becomes secondary commercialization partner for Formycon's Stelara^® biosimilar FYB202 (ustekinumab) under the brand name Fymskina^® in Germany
 

• Teva's subsidiary Ratiopharm is going to commercialize Fymskina^® as a second Formycon ustekinumab biosimilar on a semi-exclusive basis in Germany
• Market launch of Fymskina^® is planned for Q3 2025
• Formycon is responsible for the manufacturing and supply of the finished product
   

Planegg-Martinsried, Germany – Formycon AG (FWS: FYB, “Formycon”) announces that it has entered into a distribution agreement with ratiopharm GmbH (“Ratiopharm”), a subsidiary of the Teva Group (“Teva”), for the semi-exclusive commercialization of its Stelara^®1 biosimilar FYB202/Fymskina^®2 in Germany. Under the agreement, Formycon is responsible for the manufacturing and the supply of the finished product, while Ratiopharm is responsible for commercialization.

In February 2023, Formycon entered into a global commercialization partnership for FYB202/Otuli^®3 (ustekinumab) with Fresenius Kabi. Under this agreement, Formycon retained secondary commercialization rights for Germany, parts of Latin America, and the MENA region in order to also license these rights separately to strong regionally focused distribution partners. In this respect, a license and supply agreement with MS Pharma for numerous countries in the MENA region was successfully concluded in December 2024.

“We aim to provide as many patients as possible with access to high-quality biosimilars while expanding our market presence in Germany. That's why we set the strategic course for semi-exclusive partnerships early on,” explains Nicola Mikulcik, Chief Business Officer of Formycon AG. She adds: “With Fresenius Kabi, we already have a strong partner that, successfully launched FYB202/Otulfi^® in the US and various European markets, including Germany in March this year. We are delighted to have gained Teva/Ratiopharm as a strong second partner for the commercialization of FYB202 in our important home market Germany. We are convinced that we can significantly increase market coverage in Germany with this second product, FYB202/Fymskina^®.”

Teva already commercializes Formycon's Lucentis^®4 biosimilar FYB201/Ranivisio^®5 in Europe. As one of the world's leading pharmaceutical companies, Teva is leveraging its unique expertise in the generics and biosimilars market to drive the availability of modern medicines.

Under the agreement for the commercialization of Fymskina^® in Germany, Formycon will receive milestone payments and a share of the gross margin.

FYB202/Fymskina^® (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. These play an important role in inflammatory and immune responses. In September 2024, Fymskina^® was approved by the European Commission for the treatment of moderate to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.

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¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
²⁾ Fymskina^® is a registered trademark of Formycon AG
³⁾ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
⁴⁾ Lucentis^® is a registered trademark of Genentech Inc.
⁵⁾ Ranivisio^® is a registered trademark of Bioeq AG

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 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 and TecDax selection indices. Further information can be found at: https://www.formycon.com/

About Teva Germany:
Around 2,900 employees at Teva Germany work every day to simplify access to medicines for millions of people and give patients back a piece of their independence. Whether through medicines – innovative specialty medicines, generics, and over-the-counter medicines – affordable prices, or special services.

Germany's best-known pharmaceutical brand, ratiopharm, is part of Teva Germany. For over 50 years, ratiopharm stands for high-quality medicines at affordable prices. Its advertising featuring twins has now achieved classic status.

Teva's German headquarters are in Ulm. Another production site is located in Blaubeuren/Weiler.

Teva's goal is to ensure that patients receive the medicine they need, where and when they need it. To this end, 37,000 employees work around the globe. Teva offers more than 3,500 different products in around 60 countries. Find out more at: www.teva.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.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com
 

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.