A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2

A biowaiver generally refers to the request to waive an <i>in vivo</i> bioequivalence study. A biowaiver may be granted not only based on the Biopharmaceutics Classifications System (BCS) but also for many immediate-release dosage forms based on pre-defined criteria. The current paper summarises the results from a survey of the biowaiver requirements for cutaneous/topical products (topical solutions, gels, suspensions, ointments, and creams), ear/otic and ophthalmic solutions and suspensions, enemas in solution and suspension, and vaginal solid dosage forms and suppositories defined by the participants of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP). A review of the results from the survey indicates that there is a trend towards convergence when the dosage forms are less complex; however, the most common approach used by each of the participants was a case-by-case approach given that most participants do not have well-defined guidelines to support all possible scenarios. Notwithstanding the differences, disseminating information is the first step towards regulatory convergence regarding biowaivers for certain dosage forms and will be useful for pharmaceutical companies currently developing generic medicinal products for countries represented by IPRP participants.