Formycon Wins Endorsement For Second EU Lucentis Rival
CHMP Positive Opinion For Ranivisio Sets Up Approval For Ranibizumab Biosimilar
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.
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Weeks after Coherus BioSciences put pen to paper on a deal to bring in Formycon’s FYB203 proposed biosimilar to Eylea (aflibercept), the candidate has shown positive efficacy and safety data, according to preliminary Phase III trial results.
Stada and Xbrane have celebrated an endorsement from the EMA’s CHMP for their Ximluci ranibizumab biosimilar rival to Lucentis. The development follows a setback for a parallel filing in the US.
A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.