Received: 13.05.2026
Accepted: 10.08.2026
Published online: 21.08.2026
UDC: 615.1:615.015.32
DOI: 10.53511/pharmkaz.2026.4.13
BIOWAIVER IN THE GENERIC DRUG REGISTRATION SYSTEM: A NARRATIVE REVIEW OF INTERNATIONAL REGULATORY REQUIREMENTS AND PROSPECTS
FOR APPLICATION IN THE REPUBLIC OF KAZAKHSTAN
Azamatova A.K., Ustenova G.O., Mombekov S.E.
Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Introduction. A biowaiver assesses the bioequivalence of generic medicinal products using the Biopharmaceutics Classification System and comparative in vitro dissolution studies. It is relevant to Kazakhstan because of the growing share of generic medicines and the need to optimize registration procedures.
Objective. To compare international regulatory requirements for biowaivers and assess their prospects in registering generic medicinal products in Kazakhstan.
Methods. A structured narrative review was conducted with consideration of SANRA principles. Publications were searched in Scopus and Google Scholar from 1 January 2016 to 4 August 2026. Peer-reviewed original, review, and methodological articles in Russian and English were included if they provided generalizable data on BCS-biowaiver principles, regulatory requirements, solubility, permeability, comparative dissolution, excipients, or limitations. ICH, EMA, FDA, WHO, and EAEU documents and official market data from Kazakhstan were also analyzed. The final analysis included 18 scientific publications, 10 regulatory documents, and 4 official sources.
Results. Following implementation of ICH M9, the principal scientific criteria for biowaivers have been largely harmonized. This applies to solubility and permeability assessment, comparative dissolution conditions, requirements for BCS Class III products, and excipient comparability. WHO additionally requires that the difference in tablet core mass between test and comparator BCS Class III products should not exceed 20% and permits a justified alternative statistical approach for highly variable dissolution profiles. More substantial differences concern legal status, reference product selection, dossier content, and regional review practices. Official data confirm continued import dependence and growing public procurement but do not determine the number of potentially eligible products in Kazakhstan.
Discussion. Harmonization provides a common methodological framework but does not eliminate procedural differences. EAEU requirements are decisive for Kazakhstan, while ICH, EMA, FDA, and WHO documents serve as additional scientific sources. For eligible products, a biowaiver has the potential to reduce in vivo bioequivalence studies, associated costs, and development time.
Conclusion. A biowaiver may optimize the development and registration of selected immediate-release solid oral generic medicinal products. Assessing its prospects in Kazakhstan requires analysis of the State Register of Medicinal Products, laboratory and methodological preparedness, and consistent application of EAEU requirements with reference to current international guidelines.
Keywords: biowaiver, bioequivalence, generic drugs, Biopharmaceutics Classification System BCS, comparative dissolution studies, pharmaceutical market of Kazakhstan, drug registration.
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