Biocon Biologics Receives Complete Response Letter from US FDA for Biosimilar Insulin Aspart

The U.S. Food and Drug Administration (US FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart. The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022.

The Company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022, that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility, prior to the approval of the application.

In February 2023, the Company submitted a report from an independent third-party consultant, providing evidence of CAPA completion and effectiveness. However, the PAI reinspection was not scheduled prior to the goal date of October 6, 2023.

"The Company will continue to engage with the US FDA for an expeditious resolution and approval of its biosimilar Insulin Aspart application. This decision has no impact on the manufacturing or distribution of the Company's existing commercial portfolio. Biocon Biologics is committed to bringing high-quality and affordable medicines to the United States." - Company Spokesperson.

Shares of Biocon Limited was last trading in BSE at Rs. 264.65 as compared to the previous close of Rs. 263.60. The total number of shares traded during the day was 57551 in over 1489 trades.

The stock hit an intraday high of Rs. 265.45 and intraday low of 262.50. The net turnover during the day was Rs. 15219617.00.

Source : Equity Bulls

Keywords

BioconBiologics INE376G01013 CRL BiologicsLicenseApplication InsulinAspart