Formycon partners with Teva, Klinge Biopharma for commercialization of aflibercept biosimilar FYB203 (AHZANTIVE)

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In a press release, Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., announced it would partner with Klinge Biopharma GmbH and Formycon AG in commercializing FYB203, Formycon’s biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals Inc.). The semi-exclusive agreement will enable Teva to lead commercialization in designated regions of Europe, excluding Italy, and in Israel. Pending regulatory approval, the product will be marketed under the brand name AHZANTIVE.¹

Previously, Teva was established as the European commercialization partner of FYB201, Formycon's biosimilar to ranibizumab (Lucentis). Nicola Mikulcik, chief business officer of Formycon, commented on the expansion of the partnership. “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field,” she said in the press release.¹ “We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.”

Like its reference product, the biosimilar FYB203 is an anti-vascular endothelial growth factor (VEGF) agent used to treat retinal disease. Chief among those indications is neovascular age-related macular degeneration (AMD), also known as wet AMD.

In November 2024, the European Medicines Agency's Committee for Medicinal Products of Human Use issued a positive recommendation for marketing authorization of FYB203, under the brand names AHZANTIVE/Baiama. The European Commission is expected to announce a response to the authorization application in late January 2025.

In June 2024, the US Food and Drug Administration (FDA) approved the biosimilar FYB203, also known as aflibercept-mrbb. In a press release at that time, the company stated² that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that FYB203 demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference product in patients with neovascular AMD.

References

1. Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. News release. Teva Pharmaceutical Industries Ltd. Published January 13, 2025. Accessed January 13, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008103/0/en/Teva-Announces-Collaboration-to-Commercialize-Formycon-s-Biosimilar-Candidate-to-Eylea-aflibercept-in-major-parts-of-Europe-and-in-Israel.html

2. Harp M. FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive). Ophthalmology Times. Published July 2, 2024. Accessed January 13, 2025. https://www.ophthalmologytimes.com/view/fda-approves-formycon-s-biosimilar-to-eylea-aflibercept-mrbb-ahzantive-