Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.
The CRL cites additional data required in the BLA submission and an expectation of satisfactory implementation of a corrective and preventive action plan (CAPA)
Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.
The US Food and Drug Administration (USFDA) issues a Complete Response Letter (CRL) to convey to a company that its initial review of an application is complete and it cannot approve the application in its present form.
"The USFDA has issued a CRL for the Biologics License Application (BLA) for the Insulin-R product filed by Biocon Biologics," Biocon said in a regulatory filing.
The CRL cites additional data required in the BLA submission and an expectation of satisfactory implementation of a corrective and preventive action plan (CAPA) pertaining to the pre-approval inspection of the company's Bengaluru facilities in August last year, it added.
"We are in the process of comprehensively addressing the CRL," a Biocon Biologics spokesperson noted.
Biocon Biologics is a subsidiary of Biocon Ltd.