USFDA issues CRL for Insulin AspartBIOCON - 340 Change: 17.50 (5.43 %)
News: USFDA has issued a complete response letter (CRL) for the biologics licence application (BLA) for Insulin Aspart filed by Biocon’s partner Viatris (Mylan). The CRL did not identify any outstanding scientific issues with the products.
Views: CRL has been issued by USFDA on the back of a form 483 with six observations across drug substance, drug product and devices facilities post the on-site preapproval inspection of Malaysia unit. Regulatory hurdles are weighing up on Biocon’s biosimilars portfolio, which contributed 38% to the topline in FY21. Scaling up of revenue and market share of the key biosimilars and successful launch of biosimilars bevacizumab and insulin aspart are the key monitorables but delayed launches leaves Biocon with less room for growth till then. We expect Biocon’s biosimilars portfolio to grow at CAGR of 23% over FY21-24E.