Latest News | USFDA Issues CRL for Bevacizumab License Application Moved by Viatris: Biocon

New Delhi, Feb 12 (PTI) Biotechnology firm Biocon on Sunday said the US health regulator has issued a Complete Response Letter (CRL) for the biologics licence application filed for Bevacizumab by its partner Viatris.

The US Food and Drug Administration (USFDA) issues a 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.

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"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company spokesperson said in a regulatory filing.

The CRL informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022, it added.

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"We have submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and are confident of addressing the observations within the stipulated time frame," Biocon said.

Bevacizumab is a medication used to treat a number of types of cancers and a specific eye disease.

Earlier on January 7, the company had stated that the USFDA has issued a complete response letter for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)