Outcomes of Eli Lilly's attempt to get retatrutide classified as a biologic vs. a regular drug?
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Lilly files a Biologics License Application (BLA) for retatrutide
50%
Lilly files a standard New Drug Application (NDA) for retatrutide
50%
FDA rejects biologics license application for retatrutide
50%
FDA approves retatrutide as a biologic
41%
7th Circuit rules that retatrutide DOES count as a biologic
Eli Lilly wants retatrutide to be FDA approved as a biologic instead of a regular drug. There is an open legal question as to whether the molecule actually counts as a biologic.
The case is currently in appeals before the Seventh Circuit. Arguments have been heard, and a ruling is expected soon.
If the appeals court rules in Lilly's favor, and Lilly files a biologics license application, will the FDA actually approve retatrutide as a biologic?
This question is managed and resolved by Manifold.
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