ABSTRACT

Biosimilars are crucial to the pharmaceutical industry, offering cost-effective alternatives to reference biologics. India has emerged as a leader in biosimilar production, with a regulatory framework established in 2012 to ensure their quality and safety. This article covers an overview of the regulatory pathway for biosimilars in India. The regulatory framework, mirroring international standards, ensures biosimilar safety and efficacy. Key authorities, including CDSCO and DBT, play vital roles in the approval process. The process includes rigorous quality assessments, preclinical and clinical data requirements, and post-marketing surveillance. India has approved numerous biosimilars since 2000, showcasing its leadership in this field. The renewal process ensures ongoing safety and efficacy monitoring. The country’s commitment to biosimilars is a significant step toward making essential biologic treatments more accessible and affordable. Holding the promise of making essential treatments more accessible globally. The robust regulatory framework and adherence to quality control ensure that biosimilars meet stringent standards. Continued collaboration between regulatory bodies, pharmaceutical companies, and international players will be crucial as the field of biosimilars evolves. India is set to have a major impact in providing affordable and accessible biologic therapies worldwide. Keywords: Biosimilars, regulatory framework, data requirements, CDSCO, similar biologic
Publication date: 01/12/2024

https://ijbpas.com/pdf/2024/December/MS_IJBPAS_2024_8355.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2024/13.12.8355