Ranibizumab biosimilar(Formycon AG)

Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellenceAgreement 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 launchClinical development phase of FYB206 nearly completed; primary endpoint data expected in the first quarter of 2026 PLANEGG-MARTINSRIED, Germany and AHMEDABAD, India, Dec. 09, 2025 (GLOBE NEWSWIRE) -- 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. 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. Contact:Sabrina Müller, Director Investor Relations & Corporate Communications,Formycon AGFraunhoferstr. 1582152 Planegg-Martinsried Germany Tel.: +49 (0) 89 - 86 46 67 149 Fax: + 49 (0) 89 - 86 46 67 110Sabrina.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.