Israeli generics giant Teva Pharmaceutical Industries (Teva) and Swiss biotechnology company Bioeq AG announced on 28 June 2021 that they had entered into a strategic partnership for the exclusive commercialization of Bioeq’s candidate ranibizumab biosimilar (FYB201) in Europe, Canada, Israel and New Zealand.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon. Bioeq will be responsible for the development, registration, and supply of the biosimilar while Teva will be responsible for commercializing the product in Europe. The companies will share revenue from the commercialization of the biosimilar.
The strategic partnership combines Teva’s long-standing commercial presence, extensive distribution network and wide-reaching sales and marketing activities across Europe and international markets with Bioeq’s capabilities in the development of biosimilars for highly regulated countries with stringent quality standards.
On 29 June 2021, Formycon and their license partner Bioeq has submitted the marketing authorization application to the European Medicines Agency (EMA) for their biosimilar version of ranibizumab, currently known as FYB201 [2].
Bioeq and Formycon have already engaged in successful pre-Biologics License Application (BLA) interactions with the US Food and Drug Administration (FDA) [3]. The BLA-submission is expected to be filed during 2021, with submission to other highly regulated territories, such as Canada, Australia, Switzerland and the UK, expected to follow shortly afterwards.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/formycon-bioeq-submit-european-marketing-authorization-for-ranibizumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Advances for Formycon and Alteogen’s eye disease biosimilar candidates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/Advances-for-Formycon-and-Alteogen-s-eye-disease-biosimilar-candidates
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