Lilly Gets Partial Win in Suit Over FDA’s Biologic Determination

Eli Lilly & Co. notched a partial victory after a federal judge ruled the FDA arbitrarily determined that the drugmaker’s obesity and diabetes medicine, retatrutide, didn’t qualify as a biological product.

Judge Tanya Walton Pratt for the US District Court for the Southern District of Indiana agreed with Lilly that the agency acted unlawfully when it decided that retatrutide is not at least “analogous,” or comparable, to a protein in order for it to be a biological product.

The Food and Drug Administration’s determination of whether a product is a drug or biologic matters because they’re sourced and manufactured differently ...