The members of the Bioequivalence Working Group for Generics commonly grant biowaivers for non-study strengths (‘additional strengths’) under certain circumstances when bioequivalence has been demonstrated for one or two other strengths.
Surveys were conducted on the requirements for additional strength biowaivers for immediate-release and modified-release oral solid dosage forms among the member organisations and the results of the comparison of criteria were published in the Journal of Pharmacy and Pharmaceutical Sciences on 29 September 2019 and 25 October 2021, respectively.
The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
To ensure that the relevant information for additional strength biowaivers is consistently taken into account during assessment, a template for Biowaiver Assessment Report for Additional Strength(s) of Systemically Acting Immediate Release Oral Dosage Forms was developed for use by Members. The Members of the Working Group envisage that this template will also be of benefit to applicants and the broader regulatory community and have decided to make it available on the IPRP website.
The Word version available on this webpage is provided in addition to the PDF version. Non-IPRP member regulators may implement these documents within their own responsibility. IPRP is not responsible for any contents of these documents implemented by non-IPRP member authorities.