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The generic must demonstrate that its product is pharmaceutically equivalent (same active ingredient, dosage form, route of administration, and strength) and bioequivalent (no clinically significant difference in rate and extent of absorption) to the RLD
10.1093/cei/uxac123 6 Averill-BatesD
Specifically, the risk ratios for nausea ranged from 2.07 to 3.51 across different doses of tirzepatide, and from 2.45 to 2.84 for semaglutide (ESM Table 14)
doi: 10.1152/ajpgi.00293.2012 57 KoufakisT.PatouliasD.ApostolopoulouM.GeorgianosP.PopovicD
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