Formycon, Teva team up for Formycon’s biosimilar candidate aflibercept in Europe and Israel

Klinge Biopharma GmbH, the licensee and exclusive global commercialization rights holder for FYB203, Formycon’s biosimilar candidate to Eylea (Aflibercept), has signed a licensing agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel. In parallel Formycon has signed an agreement with Teva under which Formycon will supply the finished product.

Eylea is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases.

The collaboration combines Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries with Teva’s deep commercial experience in biosimilars and its extensive distribution network and -broad sales and marketing reach across Europe.

Under the licensing agreement, Teva will obtain semi-exclusive commercialization rights for major parts of Europe, excluding Italy, as well as for Israel for FYB203, Formycon’s biosimilar candidate to Eylea, to be marketed under the brand name AHZANTIVE subject to regulatory approval. In return, Klinge will receive milestone payments and royalties on net sales.

Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from this agreement. Furthermore, Formycon will receive payments for organizing the commercial market supply of AHZANTIVE on behalf of Klinge.

“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,” commented Nicola Mikulcik, CBO of Formycon AG.

Commenting on the agreement, Richard Daniell, Executive Vice President European Commercial of Teva, says: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio / Ongavia) for Lucentis 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.”