Formycon Secures License Date For Aflibercept 2 mg Biosimilar FYB203 In Europe And Further Territories Following Settlement With Regeneron And Bayer

• Settlement and licensing agreement for FYB203 (AHZANTIVE and Baiama) concluded with Regeneron and Bayer; all pending patent litigations fully resolved
• Agreement covers Europe as well as key markets in Latin America and the Asia-Pacific region
• Market launches by commercialization partners across Europe to start in May 2026

Formycon AG (“Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea¹ 2 mg biosimilars AHZANTIVE² and Baiama³. Under the terms of the agreement, both products may be launched in Europe and further territories including key markets in Latin America and Asia-Pacific from May 2026. In October 2025, Formycon had already secured the U.S. license date for FYB203 in Q4 2026 as part of an agreement with Regeneron.

“The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners. With our differentiated and regionally focused partnering strategy, we are sure that we have set the course for sustainable success of FYB203 across the European markets and beyond. For ophthalmologists and patients with severe retinal diseases, our biosimilars represent a highly effective and cost-efficient treatment option,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.

AHZANTIVE and Baiama are approved by the European Medicines Agency (“EMA”) for the treatment of neovascular age-related macular degeneration (“nAMD”) and other serious retinal diseases. The active ingredient aflibercept inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina, causing severe visual impairment.

About Formycon
Formycon AG 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. For more information, visit https://www.formycon.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.

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