ISSN : 2663-2187

Evolution Of Biosimilar Landscape: A Global Perspective

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Sidhartha Sahai Malhotra, Pavitra Solanki, Gaurav Kumar Jain, Tanveer Naved
ยป doi: 10.33472/AFJBS.6.5.2024.6589-6598

Abstract

Biosimilars, recognized as cost-effective alternatives to originator biologics while upholding safety and efficacy standards, are at the forefront of a transformative shift in healthcare. The article traces the historical development of biosimilars, emphasizing Europe's pioneering role in regulation and subsequent global expansion. It distinguishes biosimilars from generic drugs, highlighting their complexity. Key characteristics of biosimilars, including regulatory pathways, clinical trials, and their impact on therapeutic areas, are thoroughly explored. The evolving global biosimilar landscape is examined, with insights into regulatory processes in the US, Europe, and India. The article also addresses regulatory challenges and harmonization efforts, emphasizing global cooperation. Through case studies of successful biosimilar launches, it showcases their potential to reduce healthcare costs and enhance patient access. Looking ahead, the review anticipates a promising future for biosimilars, marked by expanding treatment options, cost savings, global expansion, and continued regulatory support, ultimately reshaping the healthcare ecosystem.

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