Volume: 5, Issue: 1
ABSTRACT
Biosimilars have emerged as a cost-effective alternative to biologic therapies, offering substantial potential to improve access to advanced treatments in resource-constrained settings such as India. Despite the country’s strong manufacturing capabilities and early adoption of biosimilar development pathways, their clinical uptake remains suboptimal. This review examines the knowledge gaps influencing biosimilar acceptance among Indian healthcare professionals, including physicians, pharmacists, and allied stakeholders. Evidence indicates that limited understanding of biosimilar science, concerns regarding immunogenicity and safety, ambiguity surrounding interchangeability, and inadequate pharmacovigilance systems contribute to hesitancy in prescribing and utilization. Additionally, gaps in regulatory communication and the lack of robust real-world evidence further exacerbate uncertainty. This article synthesizes current literature to identify key barriers and proposes strategic interventions, including targeted educational initiatives, strengthening pharmacovigilance frameworks, enhancing regulatory transparency, and promoting real-world evidence generation. Bridging these knowledge gaps is essential for optimizing biosimilar adoption and ensuring equitable access to biologic therapies in India.
Biosimilars, Regulatory, Pharmacovigilance


