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Viatris Believes Eylea Biosimilar Candidate Is First To Reach US FDA’s Desk

As Viatris Discloses ‘Challenging’ Orencia Biosimilar Is Part Of Pipeline Again

 
• By Dean Rudge

Viatris provided several key updates for its biosimilar pipeline during the company’s Q3 earnings call, including for its biosimilar Eylea and Botox candidates, as well as disclosing another key early-stage asset.

Eye
Viatris developed aflibercept with Momenta, now a part of J&J • Source: Shutterstock

With a host of sponsors chasing approvals for biosimilars to Regeneron Pharmaceuticals’ anti-VEGF blockbuster, Viatris has filed what is believes is the first biologics license application in the US for a biosimilar to Eylea (aflibercept), accomplishing goals of filing during 2021 and being first over the line.

Confirming that the BLA had been filed at the “end of October,” Viatris president Rajiv Malik told investors during the company’s third-quarter earnings call, “We believe this is the first biosimilar registration

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