Biosimilars: Regulatory Challenges and Market Opportunities
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- Category: Vol. 88, December 2020
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Biosimilars: Regulatory Challenges and Market Opportunities
Abstract
Aim: This article examines the regulatory challenges and market opportunities surrounding biosimilars, focusing on their potential to improve access to biologic medications while en-suring safety and efficacy. Methods: The study utilizes a review of existing literature, regulatory frameworks, and recent surveys on healthcare pro-fessionals’ knowledge regarding biosimilars, highlighting the role of regulatory authorities like the EMA and FDA in shaping market dynamics. Results: The findings reveal significant variations in bio-similar approval processes across jurisdictions, with the EMA
leading in the number of approved products. However, chal-lenges remain in educating healthcare professionals about the interchangeability and clinical equivalence of biosimilars, which impacts their adoption in clinical practice. Discussion: Enhanced pharmacovigilance and clear com-
munication from regulatory bodies are crucial for promoting biosimilars. The absence of distinct nomenclature for biosimi-lars complicates identification and traceability, leading to po-tential safety concerns. Strategies such as mutual recognition of regulatory assessments and WHO prequalification are essential for improving global access to high-quality biosimilars, par-ticularly in low-resource settings.