Regulatory Definitions and Classification of Biosimilar Medications Across the 6 Regions of the World Health Organization

How do regulatory definitions and requirements for biosimilar medications differ among the 6 global regions of the World Health Organization (WHO)?This scoping review, including guidelines from 19 countries, found that most emerging market and developing economies (as defined by the International Monetary Fund) follow the 2009 WHO guidance, but regulatory requirements vary among countries, particularly for comparability exercises, clinical and nonclinical data, and pharmacovigilance. Recent European, US, and WHO guidelines (2022) allow waiver of studies when appropriate analytical data are available, but few emerging market and developing economies have adopted similar waiver policies.These findings highlight areas in which the global regulatory framework requires greater harmonization to optimize access to biosimilar medications and to improve support for policy research and cross-country comparisons.

Corresponding Author: Jonathan H. Watanabe, PharmD, MS, PhD, Department of Clinical Pharmacy, School of Pharmacy, Clinical Sciences Building, 521 Parnassus Ave, Floor 3, San Francisco, CA 94143 (Jonathan.watanabe@ucsf.edu).

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