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
Year: 2025
Type: article
Abstract: 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.
Authors: Alfredo García-Arieta, Andrew Tam, Florencia Tiseyra, Eduardo Agostinho Freitas Fernandes, Kelen Carine Costa Soares, Raphael Sanches Pereira, Henrike Potthast, Katalina Mettke, Ya-Wen Chang, Li-Feng Hsu, Yu-Lin Su, Zulema Rodríguez Martínez, Milly Divinsky, Kevin Blake, April C. Braddy, Clare Rodrigues, Tiong Toh, Erwin Guzman Aurela, Liliana Carolina Arévalo González, Ben Jones, So Hee Kim, Choongyul Ahn, Eunju Yun, Ryosuke Kuribayashi, Kohei Shimojo, Miho Kasuga, Junya Makino, Joel Raffel, Joy van Oudtshoorn, Philda Tabane, Bader Alzenaidy, Mohammed AlHarbi, Adel Alharf, Albatool BinAjlan, Chantal Walther, Matthias S. Roost, Christopher Crane, Kitty Lee
Institutions: World Health Organization, Health Canada, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, Agência Nacional de Vigilância Sanitária, Federal Institute for Drugs and Medical Devices, European Medicines Agency, United States Food and Drug Administration, Health Sciences Authority, Ministry of Food and Drug Safety, Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Swissmedic
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $2,200
Funder: World Health Organization
OpenAlex ID: W4415364752