Teva partners with Klinge Biospharma, Formycon for Eylea biosimilar candidate in Europe, Israel
Teva Pharmaceuticals International GmbH, a subsidiary of Teva, has entered into a strategic collaboration with Klinge Biopharma GmbH and Formycon AG for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Regeneron’s Eylea (aflibercept) in Europe, excluding Italy, and in Israel.
This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in-licensed the exclusive global commercialization rights to FYB203 from Formycon.
Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name Ahzantive, subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue.
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Formycon is a leading, independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities.
Richard Daniell, executive vice president, of European commercial at Teva said, "We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio/Ongavia) in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve."
Nicola Mikulcik, CBO of Formycon, said, “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. 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.”
[Read more: Teva rolls out generic Nexavar tablets]
In June 2024, the Food and Drug Administration approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the marketing authorization of FYB203 under the brand names Ahzantive/Baiama. The European Commission's decision on approval is expected in the second half of January 2025.
Eylea is used to treat neovascular age-related macular degeneration and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor, which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea achieved global sales of approximately $9 billion, including $2.9 billion in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.