Aflibercept biosimilars Ahzantive® and Baiama® are now available in the European Union

Press Release // May 19, 2026
 

Formycon expands commercial portfolio: Aflibercept biosimilars Ahzantive^® and Baiama^® are now available in the European Union

• FYB203 (aflibercept) is now available as prefilled syringe under the brand names Ahzantive^® and Baiama^® in the European Union
• Phased rollout through multiple commercialization partners in key European markets
• Multi-partner approach reinforces market penetration and underscores Formycon’s FYB4Growth strategy

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce the launch of the Eylea^®1 2mg biosimilar FYB203 in the European Union. This marks an important milestone in Formycon's growth strategy and expands its commercial portfolio to three in-house developed biosimilars. The market launch of the Ahzantive^®2 and Baiama^®3 pre-filled syringes (“PFS”) through multiple commercialization partners began on May 15, 2026, in key European markets such as Germany, France, and Italy. The rollout in additional Central and Eastern European countries will take place step by step over the coming weeks and months.

Nicola Mikulcik, CBO of Formycon AG, said: “With the launch of Ahzantive^® and Baiama^®, we are reaching another important milestone in scaling our portfolio commercially. In line with our FYB4Growth strategy, we are positioning our biosimilar broadly across Europe’s diverse market landscape together with several strong licensing partners. This provides patients with severe retinal diseases with another safe, effective, and cost-efficient treatment option.”

In March 2026, Formycon entered into a settlement and licensing agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), ensuring the market launch in Europe starting May 15, 2026. In October 2025, Formycon had already secured the U.S. market launch for the fourth quarter of 2026 – or potentially earlier under certain circumstances – as part of an agreement with Regeneron.

Ahzantive^® and Baiama^® are being launched across Europe as pre-filled syringes. This user-friendly system was specifically designed to meet the requirements of intravitreal injections and supports the efficient and safe treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases. The Ahzantive^® and Baiama^® vials will be introduced in selected European regions over the coming months.

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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 covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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 #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term.

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 AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
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.