Biocon And Viatris Get CRL From FDA On Insulin Aspart

Biosimilar Rival To NovoLog Already Approved In Europe As Kixelle

10 Jan 2022

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.

Sign outside of FDA's headquarters in White Oak, MD — The FDA has issued a CRL over the proposed NovoLog rival • Source: Alamy

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.

While specific details of the letter were not disclosed, Biocon confirmed that “the US FDA has issued a CRL for the BLA for