In generic drug approval, what does bioequivalence require?

• A. The generic must demonstrate similar absorption and exposure to the reference product
• B. The generic must be produced by the same company as reference product
• C. The generic must have identical inactive ingredients
• D. The generic must be launched on the same date as the reference product

Answer: (A)

Bioequivalence tests whether a generic product delivers the same amount of active drug into the bloodstream in the same time frame as the reference product. This focuses on pharmacokinetics—the rate and extent of absorption. If the generic shows similar absorption and systemic exposure to the reference, its therapeutic effect and safety should match, which is why regulators compare key parameters like the rate of absorption (often reflected by Cmax) and the extent of absorption (reflected by AUC). In practice, these measures must fall within an acceptable range, typically demonstrated statistically, to establish similarity.

Inactive ingredients can differ and the generic need not be made by the same company or launched on the same date; what matters for bioequivalence is the comparable pharmacokinetic profile.