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UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage

Formycon-Bioeq Partnered Ongavia Receives First European Approval In UK

 
• By Dave Wallace

Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.

UK red on map of Europe
The UK has given Teva and partner Formycon a first European ranibizumab approval • Source: Shutterstock

Teva could now be in line for the world’s first launch of a biosimilar rival to Lucentis (ranibizumab), after the UK’s Medicines & Healthcare Regulatory Agency approved the Ongavia version that was developed by Bioeq and Formycon under the FYB201 designation.

Under an exclusive commercialization deal struck last year, Teva has rights to FYB201 in Europe, as well as Canada, Israel, and New Zealand

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