New Delhi Biocon on Sunday said the US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) filed by Vytris for Bevacizumab.
“The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Vytris (Mylan),” Biocon said in a statement.
The US health regulator issues a completed response letter to inform a company that a preliminary review of its application has been completed and the USFDA cannot approve the application in its current form.
The biotechnology major also said that the CRL intimates the need for satisfactory resolution of the observations made by the USFDA during the facility inspection in August 2022.
“We have submitted a comprehensive corrective and preventive action (CAPA) plan to the agency and are confident of addressing the objections within the stipulated time frame,” Biocon said.
In November 2022, Biocon Biologics, the biosimilar manufacturing arm of Biocon Ltd, acquired Vytris’ global biosimilar business for $3 billion.
A media report in the first week of February said that Biocon had sold 10% stake in Syngene to acquire the biosimilar business of Vytris.
Bevacizumab is used to treat several types of cancer and a specific eye disease.
On Friday, shares of Biocon Ltd closed at Rs 243, down 0.062%.
The company had on January 7 said that the USFDA has also issued a complete response letter to Biocon Biologics’ application for its proposed biosimilar Insulin-R for the treatment of diabetes.
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