Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel

Strategic Collaboration - Teva Pharmaceuticals International GmbH has entered into a strategic collaboration with Klinge Biopharma GmbH and Formycon AG for the semi-exclusive commercialization of FYB203, a biosimilar candidate to Eylea (aflibercept), in Europe (excluding Italy) and Israel [1] - The collaboration leverages Teva's commercial experience in biosimilars and its extensive distribution network across Europe, combined with Formycon's expertise in biosimilar development for highly regulated markets [2] - Klinge holds the exclusive global commercialization rights for FYB203, which will be marketed under the brand name AHZANTIVE, subject to regulatory approval [3][8] Product and Market Context - FYB203 is a biosimilar to Eylea (aflibercept), a drug used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases by inhibiting vascular endothelial growth factor (VEGF) [6] - Eylea achieved global sales of approximately USD 9 billion in 2023, including USD 2.9 billion in the European market, making it the highest-revenue drug in the anti-VEGF therapy sector [6] - The U.S. FDA approved FYB203 in June 2024, and the European Medicines Agency's CHMP issued a positive recommendation for its marketing authorization in November 2024, with a final decision expected in the second half of January 2025 [5] Company Profiles - Teva Pharmaceutical Industries Ltd is a global pharmaceutical leader with over 120 years of experience, employing approximately 37,000 people across 58 markets, and is known for its generics expertise and innovation in modern medicine [7] - Formycon AG is a leading independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, and immuno-oncology, with a portfolio that includes FYB201 (ranibizumab biosimilar) and FYB203 (aflibercept biosimilar) [4][9] - Klinge Biopharma GmbH holds the exclusive global commercialization rights for FYB203 and has a proven track record in the commercialization of biosimilars, including FYB201 in Europe [8] Strategic Implications - The collaboration builds on the successful commercialization of FYB201 (ranibizumab biosimilar) in Europe, leveraging Teva's existing commercial infrastructure and distribution channels in the ophthalmology field [5][8] - Formycon will manage the entire commercial supply chain of FYB203 for the first time, marking a significant step in its operational capabilities [5] - The partnership aligns with Teva's Pivot to Growth strategy, expanding its biosimilars portfolio and reinforcing its commitment to providing access to innovative medicines [8]