Eli Lilly sues the FDA to classify retatrutide as a biologic
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Eli Lilly's suit argues 39-amino-acid obesity candidate retatrutide should be treated as a biologic, a change that would extend exclusivity, restrict compounding and delay Medicare price negotiations.
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@gaurabEli Lilly is suing the FDA to classify retatrutide as a biologic. Retatrutide's main chain has 39 alpha amino acids. Lilly makes it with solid-phase synthesis, the standard chemistry for peptide drugs. Under FDA law, a biologic has more tha