Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers

 
• By Bridget Silverman
  
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

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Several CRLs have been issued recently because of third-party manufacturer issues. • Source: Shutterstock

In an unscripted moment of synchronicity, the complete response letter for linvoseltamab announced by Regeneron Pharmaceuticals, Inc. on 20 August exemplified the findings of a US Food and Drug Administration analysis of biologics approvals presented to a Duke-Margolis Institute for Health Policy meeting the same day.

Key Takeaways

  • The FDA’s complete response for Regeneron’s linvoseltamab rests on findings from an inspection for another company’s candidate that uses the same third-party manufacturer, echoing previous CRLs for Checkpoint’s cosibelimab and Lilly’s lebrikizumab.

Regeneron said the linvoseltamab CRL listed one approvability issue related to “findings from a pre-approval inspection at a third-party fill/finish...

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