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Regulatoryretatrutideeli lillyfdaobesity

Lilly presses FDA for biologic status on retatrutide as filing nears

Classification decides whether the obesity candidate gets 12 years of exclusivity under a BLA or five under an NDA, a gap worth tens of billions.

DO
By Daniel Okafor · Regulatory Correspondent
Aug 5 03:00 ETSource: BioSpace

The wire

  1. 01Lilly sued the FDA in September 2024 after the agency ruled retatrutide is neither a protein nor a biologic; the company says its 41 amino acids exceed the 40-amino-acid protein threshold.
  2. 02Exclusivity hinges on the pathway: a BLA confers 12 years versus five for an NDA, shaping generic and biosimilar timing for a major incretin candidate.
  3. 03Courts vacated the FDA designation but sent the 'analogous to a protein' question back to the agency; Lilly has appealed and says it will still pursue a BLA.

From the source

Lilly, FDA retatrutide biologic dispute comes to a head as submission nears

Is Eli Lilly’s up-and-coming obesity medicine a biologic? The FDA doesn’t appear to think so, and that opinion could shape how the company can file the potential blockbuster for approval and the years of market exclusivity that will follow.

Read at biospace.com
Source URL https://www.biospace.com/fda/lilly-fda-retatrutide-biologic-dispute-comes-to-a-head-as-submission-nears