Abstract

The emergence of biosimilars has transformed the biopharmaceutical landscape, providing cost-effective alternatives to originator biologics. However, ensuring the quality, safety, and efficacy of biosimilars presents unique regulatory challenges. This article explores the regulatory framework surrounding biosimilars and the analytical approaches employed for quality control. Key methodologies, including physicochemical characterization, biological assays, and stability testing, are discussed in detail. The discussion highlights the critical role of analytical strategies in demonstrating biosimilarity and addressing regulatory concerns. Finally, the article concludes with recommendations for harmonizing global regulatory standards and enhancing the quality control processes for biosimilars.