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Biocon Knocked Back By FDA On Human Insulin

Biosimilar Filing Receives CRL Citing Need For More Data And Facility Remediation

 
• By Dave Wallace

Biocon has seen its insulin-R application knocked back by the US FDA, with a complete response letter citing a need for more data as well as the need for remediation activities at its Bangalore facilities.

Insulin wireframe of syringe and vial
Biocon has received a setback on human insulin • Source: Shutterstock

Biocon has received a setback in its attempts to gain US approval for human insulin, after the US Food and Drug Administration issued a complete response letter calling for more information on the filing, as well as urging the biosimilars developer to deliver on remediation plans at its Indian manufacturing facilities in Bangalore.

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