The generic pathway does not typically require the same comparative clinical trial programs expected for biosimilars, but instead relies on demonstrating pharmaceutical equivalence and bioequivalence
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Clinical trials reflect an average weight loss of 22.5% over 72 weeks for participants on the highest dose
GLP-1 RAs also improve insulin sensitivity, reduce ectopic fat deposition, and modulate adipose tissue metabolism by stimulating lipolysis and inhibiting lipogenesis [12, 13]
Serious side effects are rare but have occurred
( Lancet 2023, NCT04982575 [12] ) randomised 92 adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor, 1:1:1 to CagriSema (n=31), semaglutide (n=31), or cagrilintide (n=30), all escalated to 2.4 mg, across 17 US sites over 32 weeks