Formycon AG and its partners have announced a series of key achievements, securing the US market path for its aflibercept biosimilar and expanding its global ophthalmology portfolio.
The company, alongside license partner Klinge Biopharma and Valorum Biologics, announced on 2 October 2025 a settlement with Regeneron Pharmaceuticals. This resolves US patent litigation for its Eylea (aflibercept) biosimilar, Ahzantive/FYB203 (aflibercept-mrbb), approved by the EC on 28 June 2024 [1]. Under the agreement, Valorum is permitted to launch Ahzantive (aflibercept-mrbb) in the US in the fourth quarter of 2026, or earlier under certain conditions.
This major milestone was bolstered by recent global licensing agreements for FYB203/aflibercept biosimilar. On 16 October 2025, partner Klinge Biopharma (Klinge) signed deals with Actor Pharma to commercialize the product in Australia and with Megalabs for Latin America. Formycon will receive a share of the payments to Klinge and will organize the supply chain, with regulatory applications already submitted in Australia.
This follows a semi-exclusive agreement signed on 17 September 2025 with Horus Pharma for the commercialization of FYB203/aflibercept (marketed as Baiama) in selected European countries. Baiama received EC approval in 2024 [2].This was preceded by another semi-exclusive agreement in January 2025agreement between Klinge and Teva Pharmaceuticals for the commercialization of Ahzantive (FYB203/aflibercept) in major parts of Europe (excluding Italy) and Israel [3].
In a separate development, Formycon, Bioeq and Teva announced on 21 October 2025 the launch of FYB201/Ranivisio, the first Lucentis biosimilar in Europe available in an innovative pre-filled syringe (PFS). The rollout began in France, with Germany and other countries to follow. Ranivisio received EC approval on 29 August 2022 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
2. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, eight more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-eight-more-await-final-authorization
3. GaBI Online - Generics and Biosimilars Initiative. Klinge-Teva and MS Pharma agreements for Eylea and Stelara biosimilars in Europe and MENA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/pharma-news/klinge-teva-and-ms-pharma-agreements-for-eylea-and-stelara-biosimilars-in-europe-and-mena
4. GaBI Online - Generics and Biosimilars Initiative. EC approves ranibizumab biosimilar Ranivisio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/news/ec-approves-ranibizumab-biosimilar-ranivisio
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