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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