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WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
1. Introduction and background:
The World Health Organization (WHO) recognizes the possibility to waive in vivo bioequivalence studies for immediate-release, solid oral dosage forms with active pharmaceutical ingredients (APIs) belonging to Class I and III according to the Biopharmaceutics Classification System (BCS), using comparative dissolution studies as surrogate proof of bioequivalence (1).
The WHO solubility classification, also referred to as the “WHO Biowaiver List”, is a tool for national regulatory authorities (NRAs) and pharmaceutical manufacturing companies, suggesting medical products that are eligible for a waiver from in vivo bioequivalence studies, which are usually necessary to establish the therapeutic equivalence with the originator (comparator).
As part of its 2006 guidance on the waiving of bioequivalence requirements for immediate-release, solid oral dosage forms on the WHO Model List of Essential Medicines (2), WHO had provided a list of APIs based on data extracted from the public domain (i.e. solubility data published by different authors using inconsistent experimental conditions) (3).
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WHO TRS (Technical Report Series) 1025, 2020 Annex 12:
