The Influence of Regulatory Changes on Market Entry Strategies for Biosimilars

Lucky Jha
ABESIT

Crossings Republik, Ghaziabad, Uttar Pradesh 201009
luckyjha200405@gmail.com

Abstract

Biosimilars have emerged as critical therapeutic alternatives to innovative biologics, promising increased patient access and reduced healthcare costs. However, their market entry is intricately shaped by evolving regulatory frameworks. This study examines the influence of regulatory changes on the market entry strategies adopted by biosimilar developers. Through a detailed literature review, statistical analysis, and empirical evidence, the manuscript identifies key regulatory shifts and evaluates how these changes affect strategic decisions, including pricing, market positioning, and competitive dynamics. The findings reveal that clear regulatory guidelines, harmonized standards, and expedited approval processes significantly enhance market entry, while regulatory uncertainties act as barriers. The paper concludes by proposing actionable strategies for biosimilar companies to navigate regulatory challenges and suggests directions for future research in this evolving domain.

Keywords

Biosimilars; Regulatory Changes; Market Entry Strategies; Biopharmaceuticals; Healthcare Policy

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