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

Collaboration Overview - Teva collaborates with Formycon and Klinge for the commercialization of FYB203, a biosimilar to Eylea® (aflibercept), in Europe (excluding Italy) and Israel [12] - Teva will lead the commercialization of FYB203 under the brand name AHZANTIVE®3, subject to regulatory approval [2] - Klinge holds exclusive global commercialization rights for FYB203 and will receive milestone payments and a portion of the product's revenue [1][2][7] Company Profiles - Teva is a global pharmaceutical leader with over 120 years of experience, employing ~37,000 people across 58 markets, and focuses on generics and innovative medicines [6] - Formycon is a leading independent developer of high-quality biosimilars, focusing on ophthalmology, immunology, and immuno-oncology, with a strong presence in Europe and the USA [3][8] - Klinge Biopharma GmbH holds exclusive global commercialization rights for FYB203 and has a proven track record in biosimilar commercialization [7] Product and Market Context - FYB203 is a biosimilar to Eylea® (aflibercept), which is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases [5] - 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 [5] - FYB203 received FDA approval in June 2024 and a positive recommendation from the EMA's CHMP in November 2024, with European Commission approval expected in January 2025 [4] Strategic Implications - The collaboration builds on the successful commercialization of FYB201 (ranibizumab biosimilar) in Europe, leveraging Teva's existing commercial infrastructure and distribution channels [4][7] - Formycon will manage the entire commercial supply chain of FYB203 for the first time, marking a significant step in its operational capabilities [4] - The partnership aligns with Teva's Pivot to Growth strategy, expanding its biosimilars portfolio and enhancing access to innovative medicines [7]