USFDA rejects proposed Biocon's Insulin Aspart application in CRL

USFDA issued Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment.

The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form.

"The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing.

 

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the application, it added.

"The company will continue to engage with the USFDA for an expeditious resolution and approval of its biosimilar Insulin Aspart application. This decision has no impact on the manufacturing or distribution of the company's existing commercial portfolio," the spokesperson said.

Biocon Biologics is a subsidiary of Biocon Ltd.