Formycon and its license partner Klinge Biopharma have announced a settlement and licensing agreement with Regeneron and Bayer Healthcare, resolving all patent disputes related to their Eylea¹ (aflibercept) biosimilars Ahzantive² and Baiama³ in Europe and other global markets.

Under the terms of the agreement, the two biosimilars—approved in the European Union—will be eligible for launch beginning in May 2026 across Europe as well as in additional territories, including key markets in Latin America and the Asia-Pacific region. 

In October 2025, Formycon secured a US license date for its aflibercept biosimilar FYB203 to be effective in the fourth quarter of 2026 through a separate arrangement with Regeneron.

“The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners,” said Nicola Mikulcik, Chief Business Officer of Formycon. “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.”

Ahzantive and Baiama have been approved by the European Medicines Agency for the treatment of wet age-related macular degeneration (AMD) and other retinal conditions. 

References

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