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Congress and the FDA responded with provisions in the FDA Safety and Innovation Act requiring innovators to provide REMS-compliant access to reference product samples for bioequivalence testing [23]

DIO mice were randomized to treatment according to body weight (n = 15 per group) and dosed subcutaneously (5 ml/kg) for a total of 28 days with vehicle (QD), liraglutide (0.2 mg/kg, BID) or GUB09-145 (0.04 mg/kg, BID)

"Beyond GLP-1: the next wave of weight-loss medication innovation." October 2025