Partners Viatris and Biocon have seen their efforts to secure a US approval for a biosimilar rival to NovoLog (insulin aspart) stymied after the US Food and Drug Administration issued a complete response letter over their biologics license application.
Biocon And Viatris Get CRL From FDA On Insulin Aspart
Biosimilar Rival To NovoLog Already Approved In Europe As Kixelle
Viatris and partner Biocon have suffered a setback over their proposed insulin aspart biosimilar rival to NovoLog in the US, after the FDA issued a CRL relating to the filing.
More from Biosimilars
• By
In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
• By
Generics Bulletin reviews global regulatory developments across the world.
• By
Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.
• By
After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?
More from Products
• By
Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.
• By
Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.
• By
After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?