Tag: FDA

Complex Generic Formulations: Why Proving Bioequivalence Is So Hard

Complex Generic Formulations: Why Proving Bioequivalence Is So Hard

Jan 10 2026 / Medications

Proving bioequivalence for complex generics like inhalers, creams, and patches is far harder than for regular pills. Without blood-level tests, manufacturers face reverse-engineering challenges, unstable formulations, and conflicting global standards - delaying affordable alternatives.

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