Bengaluru: Biocon Biologics has announced that 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 the company's Malaysia facility for Insulin Aspart, held in August 2022," The Company's spokesperson said in a BSE filing.
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, ” the spokesperson added.
Read also: Biocon arm gets multiple USFDA observations across India, Malaysia
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. Biocon Biologics has eight commercialized products in global markets. The company has a portfolio of biosimilar assets, including insulins, monoclonal antibodies and conjugated recombinant proteins in therapeutic areas such as diabetology, oncology, immunology, and ophthalmology. Biocon Biologics has invested over USD 1 billion to date in R&D and global scale manufacturing and has end-to-end capabilities for producing drug substance, drug product and delivery devices across multiple sites in India and Malaysia.
Read also: Biocon collaborates with Juno Pharma for commercialization of diabetes treatment Liraglutide in Canada
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