Formycon Partners with Teva and Klinge Biopharma for Commercialization of Aflibercept Biosimilar FYB203 (AHZANTIVE)

Formycon AG, in partnership with Teva Pharmaceuticals International GmbH and Klinge Biopharma GmbH, has announced a collaborative agreement for the commercialization of FYB203, a biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals Inc.). The partnership was detailed in a press release, highlighting its role in expanding access to biosimilar treatments for retinal diseases.

Commercialization Details

Under the semi-exclusive agreement:

       • Teva will lead commercialization efforts in specific regions of Europe (excluding Italy) and in Israel.

       • The product will be marketed under the brand name AHZANTIVE, pending regulatory approval.

Strengthening an Existing Partnership

This collaboration builds on an established partnership between Formycon and Teva. Previously, Teva was selected as the European commercialization partner for FYB201, Formycon’s biosimilar to ranibizumab (Lucentis).

Nicola Mikulcik, Chief Business Officer of Formycon, emphasized the strategic benefits of this expanded 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.”

Formycon also highlighted that this marks the company’s first-time responsibility for managing the entire commercial supply chain of the finished product.

About FYB203

FYB203 is a biosimilar to aflibercept, an anti-vascular endothelial growth factor (VEGF) agent designed to treat retinal diseases, including neovascular (wet) age-related macular degeneration (AMD).

Regulatory Progress

       • In November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE/Baiama.

       • The European Commission is expected to announce its decision on the authorization application by late January 2025.

Conclusion

The partnership between Formycon, Teva, and Klinge Biopharma represents a significant step forward in the development and distribution of biosimilars for retinal diseases. By leveraging Teva’s established commercial infrastructure, FYB203 (AHZANTIVE) is poised to expand treatment options for patients across Europe and Israel, pending regulatory approval.