Teva Pharmaceuticals, Klinge Pharma and Formycon join forces to commercialise Eylea biosimilar

Published: 14-Jan-2025

FYB203, which will be marketed under the name AHZANTIVE®3 if approved by the EMA, will be commercialised by Teva Pharmaceuticals in the majority of Europe and Israel

Teva Pharmaceuticals International has partnered with Klinge Pharma and Formycon to commercialise Eylea biosimilar candidate, FYB203. 

Through this deal, Teva will be responsible for the semi-exclusive commercialisation and distribution of the drug in both Europe (excluding Italy) and Israel.

To ensure the therapeutic is widely adopted, Teva will utilise its broad sales and marketing reach across Europe. 

Klinge has in-licensed the exclusive global commercialisation rights to FYB203 from Formycon.

 

AHZANTIVE®3

Under the terms of this agreement, Teva will commercialise FYB203 under the name AHZANTIVE 3 if the drug is approved.

Klinge will then receive milestone payments and a cut of the product's revenue, as the company has in-licensed the exclusive global commercialisation rights to FYB203 from Formycon.

Eylea, or aflibercept, is a VEGF inhibitor commonly used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases.

The therapeutic made around USD $9bn in profit in 2023, with $2.9bn of this being through sales within the European market. 

FYB203 gained US Food & Drug Administration (FDA) approval in June 2024, though the drug is currently awaiting approval from the European Medicines Agency (EMA), who has previously issued a positive recommendation for the drug's marketing authorisation.

The Commission's decision is expected in the second half of January 2025.

Richard Daniell, Executive Vice President, European Commercial at Teva said: "We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialisation of ranibizumab biosimilar (Ranivisio®4/Ongavia®5) 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, concluded: “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.”

 

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