AUTHOR=García-Arieta Alfredo , Tam Andrew , Tiseyra Florencia , Fernandes Eduardo Agostinho Freitas , Soares Kelen Carine Costa , Pereira Raphael Sanches , Potthast Henrike , Mettke Katalina , Chang Ya-Wen , Hsu Li-Feng , Su Yu-Lin , Martínez Zulema Rodríguez , Divinsky Milly , Blake Kevin , Braddy April C. , Rodrigues Clare , Toh Tiong , Aurela Erwin Guzman , González Liliana Carolina Arévalo  , Jones Ben , Kim So Hee , Ahn Choongyul , Yun Eunju , Kuribayashi Ryosuke , Shimojo Kohei , Kasuga Miho , Makino Junya , Raffel Joel , van Oudtshoorn Joy , Tabane Philda , Alzenaidy Bader , AlHarbi Mohammed , Alharf Adel , BinAjlan Albatool , Walther Chantal , Roost Matthias S. , Crane Christopher , Lee Kitty 

TITLE=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

JOURNAL=Journal of Pharmacy & Pharmaceutical Sciences

VOLUME=Volume 28 - 2025

YEAR=2025

URL=https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.14721

DOI=10.3389/jpps.2025.14721

ISSN=1482-1826

ABSTRACT=A biowaiver generally refers to the request to waive an in vivo 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.