Biocon partner Viatris gets Complete Response Letter from USFDA for Bevacizumab license application

Written by Ruchika Sharma Published On 2023-02-13T11:13:27+05:30 | Updated On 13 Feb 2023 11:18 AM IST

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

Bangalore: Biotechnology firm Biocon has announced that 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.

"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.

"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.

Read also: Biocon Chief Kiran Mazumdar Shaw leads investment in women's health platform Gytree

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.

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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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751