US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide

 
• By Cathy Kelly
  
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An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

Lilly is Seeking Biologics Status for its investigational obesity agent. • Source: Shutterstock

Eli Lilly and Company’s recently filed lawsuit against the US Food and Drug Administration seeking to overturn the agency’s refusal to designate the company’s investigational obesity agent retatrutide a biologic may forge a new path toward extended market exclusivity and unfettered pricing.

Key Takeaways

  • Lilly’s effort to overturn the FDA’s conclusion that retatrutide is not a biologic could extend the agent’s market exclusivity, as well as the time until it is subject to Medicare price negotiation.

Lilly filed the complaint 3 September in Indiana federal court after the agency declined the company’s request to designate retatrutide...

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An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

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