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Formycon Wins Endorsement For Second EU Lucentis Rival

CHMP Positive Opinion For Ranivisio Sets Up Approval For Ranibizumab Biosimilar

 
• By Dave Wallace

Formycon has seen its FYB201 ranibizumab biosimilar rival to Lucentis recommended for approval by the EMA’s CHMP, under the name Ranivisio. Teva has rights to market the product in Europe and is preparing for launch.

EU Flag Eye Close-Up
Formycon’s biosimilar is the second approved EU rival to Lucentis • Source: Shutterstock

Formycon and its licensing partner Bioeq have celebrated receiving a positive opinion from the Committee for Medicinal Products for Human Use within the European Medicines Agency, recommending granting a pan-European marketing authorization for the firms’ FYB201 biosimilar rival to Lucentis (ranibizumab) under the name Ranivisio.

The positive opinion represents the second biosimilar version of Lucentis to be endorsed by the EMA, following Samsung Bioepis receiving the first positive opinion for a Lucentis biosimilar with its Byooviz version a year ago

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