A qualitative study on harmonization of Regulatory Requirements for biosimilars in terms of Quality non clinical and clinical aspects

Abstract

ABSTRACT newlineAccess to safe, effective and affordable medication is the right of every newlinepatient. Biosimilars provide an inexpensive alternative to innovator biologics newlinewhile being comparable in terms of quality, safety and efficacy. The newlineregulatory framework for pharmaceuticals in general and biologics in newlineparticular is a complex system which requires in-depth understanding of newlineregulatory requirements across different countries. This research work newlinefocussed on the differences in the guidelines and the expectations for approval newlineof biosimilars across the regulated markets. newlineThis research work compared the regulatory guidelines from World Health newlineOrganization, United States Food and Drug Administration, European newlineMedicines Agency, Central Drug Standard Control Organization (India), newlineHealth Canada, Therapeutic Goods Administration (Australia), Ministry of newlineFood and Drug Safety (South Korea) and Pharmaceutical and Medical Device newlineAgency (Japan) and highlighted the differences in their specific criteria, newlineprocess and requirements. The approved biosimilars of pegfilgrastim, newlineetanercept, infliximab, trastuzumab and adalimumab by selected regulatory newlineagencies were compared for their quality, non-clinical and clinical data to newlineunderscore the differences and it was observed that the approval process and newlineflexibility of the regulatory agencies depends on various factors such as data newlineavailable from already approved drugs, complexity of the structure, newlinemechanisms of action, availability of pharmacodynamics markers, etc. newlineEssentially, this study offers an insight into harmonization of regulatory newlinerequirements for biosimilars. It presents a thorough overview of the present newlinesituation, pinpoints areas for progress, and underscores the need for further newlinecollaboration. newline