Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

Authors

  • Matthias S. Roost Swissmedic, Schweizerisches Heilmittelinstitut, Bern, Switzerland
  • Henrike Potthast 2European Medicines Agency’s (EMA) Pharmacokinetics Working Party and Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany
  • Chantal Walther Swissmedic, Schweizerisches Heilmittelinstitut, Bern, Switzerland
  • Alfredo García-Arieta WHO Prequalification of Medicines Programme, and Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain
  • Ivana Abalos Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Ciudad Autónoma de Buenos Aires, Argentina
  • Eduardo Agostinho Freitas Fernandes
  • Gustavo Mendes Lima Santos Agência Nacional de Vigilância Sanitária (ANVISA), Brasília, Brazil; 8Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Ciudad de México, Mexico
  • Zulema Rodríguez Martínez Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Ciudad de México, Mexico
  • Andrew Tam Health Canada, Ottawa, Ontario, Canada
  • Clare Rodrigues Health Sciences Authority, Health Products Regulation Group, Pre-Marketing Cluster, Therapeutic Products Branch, Singapore, Singapore
  • Diego Alejandro Gutierrez Triana Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia
  • Erwin Guzmán Aurela Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia
  • Nayive Rodríguez Rodríguez Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia
  • Sang Aeh Park Ministry of Food and Drug Safety, Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea
  • Jayoung Kim Ministry of Food and Drug Safety, Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea
  • Rami Kariv Ministry of Health (Israel), Pharmaceutical Division, Jerusalem
  • Milly Divinsky Ministry of Health (Israel), Pharmaceutical Division, Jerusalem
  • Ben Jones New Zealand Medicines and Medical Devices Safety Authority (Medsafe), Ministry of Health, Thorndon, Wellington, New Zealand
  • Ryosuke Kuribayashi Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan
  • Aya Myoenzono Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan
  • Miho Kasuga Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan
  • Joy van Oudtshoorn South African Health Products Regulatory Authority (SAHPRA), Loftus Park, Arcadia, Pretoria, South Africa
  • Jo-Feng Chi
  • Wen-Yi Hung Taiwan Food and Drug Administration (TFDA), Nangang, Taipei, Taiwan, R.O.C
  • Li-Feng Hsu Center for Drug Evaluation (CDE), Taipei, Taiwan R.O.C.
  • Christopher Crane Therapeutic Goods Administration (TGA), Woden, Australia
  • Tony Jarman Therapeutic Goods Administration (TGA), Woden, Australia
  • April C. Braddy U.S. Department of Health and Human Services, Food and Drug Administration (USFDA), Center for Drug Evaluation and Research, Office of Generic Drugs, Silver Spring, Maryland, USA.

DOI:

https://doi.org/10.18433/jpps32260

Abstract

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

Downloads

Download data is not yet available.

Downloads

Published

2021-10-25

How to Cite

Roost, M. S., Potthast, H., Walther, C., García-Arieta, A. ., Abalos, I. ., Agostinho Freitas Fernandes, E. ., … Braddy, A. (2021). Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities. Journal of Pharmacy & Pharmaceutical Sciences, 24, 548–562. https://doi.org/10.18433/jpps32260

Issue

Section

Review Articles