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@article{206164,
        author = {G.Sahithi and Md.Malika Sultana and P.Harshavardhan and G.Alekhya and Dr.M.V.Nagabhushanam},
        title = {Comparative Review of Biosimilar Regulatory Frameworks in the United States, European Union, and India: Approval Pathways, Market Access, and Future Perspectives},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {2},
        pages = {378-385},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=206164},
        abstract = {Biosimilars are biologic medical products that are highly similar to approved reference biologics, with no clinically meaningful differences in safety, purity, or potency. They help reduce healthcare costs and improve patient access to expensive biologic therapies used in diseases such as cancer, autoimmune disorders, and diabetes. Regulatory frameworks for biosimilars differ across regions, where the United States, European Union, and India representing major markets with varying regulatory stringency, pricing policies, and market adoption. In India, the Central Drugs Standard Control Organization collaborates with the Department of Biotechnology to regulate biosimilars. The European Union has the most established framework under the European Medicines Agency, approving its first biosimilar, Omnitrope, in 2006, and achieving the highest market penetration, with biosimilars capturing 50–80% of therapeutic areas. The U.S. pathway, established under the Biologics Price Competition and Innovation Act, has led to increasing approvals, though overall adoption remains moderate. The study evaluates biosimilar approval pathways, clinical and analytical data requirements, review timelines, pricing structures, and market penetration trends. India has strong biosimilar manufacturing, but overall market uptake is limited by regulatory and access challenges. The global biosimilar market has grown rapidly over the past two decades, reflecting the need for cost-effective biologic alternatives and enhanced patient accessibility worldwide. Overall, the comparative analysis demonstrates that balanced regulatory oversight, efficient approval pathways, and supportive pricing policies are essential to enhance biosimilar accessibility, affordability, and global market growth.},
        keywords = {Biosimilars, Biologic therapies, Reference biologics, Regulatory frameworks, Market access, Pricing policies, United States, European Union, India, Healthcare costs, Regulatory Stringency.},
        month = {July},
        }