Abstract: Objective：To investigate FDA issued guidance on Bioequivalence Recommendations for Specific Products related with highly variable drugs. Methods：Bioequivalence Recommendations for Specific Products related with highly variable drugs was investigated in multiple aspects， including bioequivalence study designs， selection of bioequivalence subjects， dosage， selection of reference products， analytes to measure， bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceutics Classification System. Results：Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment， as an extension and implement to the guideline involved in the aspect of bioequivalence. Conclusion： Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China， since CFDA haven’t released similar guidance on specific highly variable drugs.