BIOSIMILARS AND BIOBETTERS IN INDIA: REGULATORY FRAMEWORK, SCIENTIFIC CHALLENGES, AND IMPLEMENTATION STRATEGIES – A COMPREHENSIVE REVIEW

Abstract

Background: In response to India's increasing need for cutting-edge treatments, biosimilars provide an affordable substitute for pricy original biologics. A regulatory framework for biosimilar approval has been established by the Central Drugs Standard Control Organisation (CDSCO), with a focus on post-marketing safety monitoring, clinical comparability, and analytical similarity. The purpose of this review is to critically examine the scientific, regulatory, and implementation environment surrounding biosimilars and biobetters in India, with a focus on present issues and potential future paths. Methods: With an emphasis on stakeholder perceptions, pharmacovigilance, and regulatory compliance, a narrative synthesis of Indian biosimilar guidelines, scientific development pathways, and practical implementation barriers was carried out. Findings: With a strong regulatory environment and expanding domestic production capacity, India has become a global centre for biosimilars. Nonetheless, there are still issues with post-marketing surveillance, immunogenicity evaluation, and clinical trial design. Although they need specific regulatory pathways, biobetters, as next-generation biologics, represent an emerging innovation space. Enhancing biosimilar adoption and guaranteeing patient safety requires capacity-building, regulatory harmonisation, and stakeholder education. In conclusion, maximising the potential of biosimilars and biobetters in India requires improving pharmacovigilance systems, encouraging local innovation, and fortifying regulatory infrastructure. In line with national health priorities, strategic policy interventions can further enhance therapeutic affordability and accessibility.