Biowaiver based on biopharmaceutics classification system: Considerations and requirements

Abstract

Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the US, Europe, and other developing markets. Only pharmaceutical products that meet the regulatory requirements for solubility, diffusion, and permeability will be granted a biowaiver. Due to high solubility and considerable permeability, BCS class I and class III drugs are highly preferred for biowaiver by regulatory agencies. The World Health Organization recently expanded the scope of the biowaiver acceptance by considering all BCS classes. These techniques can cut down on time and money spent on ineffective bioequivalence studies. In the present article, an attempt has been made to cover the prerequisites and guidelines for biowaiver approval of a generic product, a topical system, oral films, and BCS class II and IV drugs.

Keywords

Biowaiver / Biopharmaceutics classification system / Bioequivalent / Solubility / Permeability / Generics

Author Contributions

Pratik R. Dhake: Writing - original draft.

Smita T. Kumbhar: Methodology; Resources; Writing - original draft.

Vinod L. Gaikwad: Conceptualization; Methodology; Project administration; Resources; Supervision; Writing - review & editing.

All authors have read and approved the final manuscript.

Data availability

Not applicable.

Ethics approval

Not applicable.

Funding information

There was no funding received from any agency for the preparation of this article.

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Acknowledgments

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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