FDA rejects Biocon Biologics BLA for Insulin-R product

Biocon Limited, an Indian biopharma company, said that its subsidiary Biocon Biologics has been issued a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the biologics license application (BLA) for the Insulin-R product.

The FDA has rejected the BLA seeking more data to support its submission and an expectation of satisfactory implementing a corrective and preventive actions (CAPA) plan regarding the pre-approval inspection of Biocon Limited’s facilities in August 22.

FDA rejects Biocon Biologics BLA for Insulin-R product. Photo courtesy of Biocon.

A company spokesperson of Biocon Biologics said: “We are in the process of comprehensively addressing the CRL.”

In late 2022, Biocon Biologics completed the previously announced $3.3 billion acquisition of the biosimilars business of US-based pharma company Viatris.