Biocon Biologics gets complete response letter from USFDA for proposed biosimilar Insulin-R
Bangalore: Biopharmaceutical company Biocon has announced that 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.
Read also: Biocon Biologics recognized as Company with Great Managers at Great Manager Awards 2022
Biocon Limited is an innovation-led global biopharmaceuticals company headquartered in Bangalore. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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