Why Dissolution Testing Alone Is Not Sufficient for Generic Drug Approval: Bioequivalence Studies in Ensuring Therapeutic Equivalence

Generic medicines play a vital role in improving access to affordable healthcare worldwide. Compared with innovator or reference products, generic drugs are generally available at a lower cost, making them an important option for patients and healthcare systems. However, regulatory authorities must ensure that generic medicines meet the same standards of quality, safety, and efficacy as the reference products. In highly regulated markets such as the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), and Health Canada, bioequivalence studies are generally required for generic drug approval. In contrast, some low- and middle-income countries have historically granted approval for certain generic products based primarily on in-vitro dissolution data because of socioeconomic considerations, limited resources, and the high cost associated with conducting bioequivalence studies.

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