RAPS: FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs

The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs). The list targets what trials should be run by those developing a number of new generic oncology treatments, though many have yet to lose patent protection and some were recently approved, including Pfizer’s breast cancer drug Ibrance (palbociclib), Eisai’s thyroid cancer drug Lenvima (lenvatinib mesylate) and Novartis’ basal cell carcinoma treatment Odomzo (sonidegib phosphate).