FDA Guidelines for Bioequivalence

The FDA guidelines for bioequivalence have been established to ensure primarily that generic drug manufacturers are producing drugs equivalent to the non-generic versions. The requirements are also in place to ensure the drugs are as safe and work as well as brand-name medicines.

Definition

• According to Merck, bioequivalence means that the generic version of a drug releases its active ingredient into the bloodstream at virtually the same speed and in virtually the same amounts as the original drug. Bioequivalence studies compare two drug products, and the new medication must be equivalent to the original in both the rate and extent of exposure in the body.

Basic Requirements

• The Generic Pharmaceutical Association states that the federal laws, and subsequently FDA approval of a generic drug product, require that the generic "contain the same active ingredient as the brand-name counterpart, be the same strength and dosage form (tablet, capsule, etc.), and have the same route of administration (oral, topical, injectable, etc.)." The other basic requirement is that the generic drug work in a similar way and also have the same safety and efficacy profile.

FDA Perspective

• The FDA has stated that a less than 5 percent difference in blood levels is required between brand name and generic medicines. The FDA also frequently states that the bioequivalence requirements are challenging and rigorous enough to ensure generic drugs are as close to brand name medicines as possible.