The CDSCO has released revised draft guidelines on biosimilars, inviting industry feedback by June 5, 2025, to bring India’s standards in line with global practice.
The Central Drugs Standard Control Organisation has opened public consultation on its 2025 Draft Guidelines for Similar Biologics, outlining new rules for marketing biosimilars in India and asking stakeholders to submit comments by June 5. According to the notification, “In view of advances in scientific knowledge and experience, it was decided to revise the existing guidelines”. A committee of technical experts, representatives from the National Institute of Biologicals and the Department of Biotechnology, and industry members framed the revisions.
Originally issued in 2012 and updated in 2016, the guidelines now reflect key international standards and offer a clearer, more flexible pathway for marketing authorization of biosimilars in India. The draft covers reference standards, manufacturing processes, analytical requirements, preclinical data, waivers for safety and efficacy studies, and post‑market risk management plans.
Biosimilars—or “similar biologics”—are complex medicines derived from living cells that match approved biologics in safety, purity, and potency. As patents on many originator biologics expire, the market opportunity grows: India’s biologics sector, valued at about $1 billion (₹8,400 crore), could double by 2030.
Under the new draft, applicants must demonstrate structural and functional similarity to a Reference Biological Product (RBP) approved in India or an ICH country. Analytical similarity exercises must draw on multiple batches of RBP and the biosimilar, using sensitive, orthogonal methods. In vitro studies should assess binding and functional activity; in vivo animal studies may be waived if in vitro data show high similarity. Clinical studies—ranging from pharmacokinetic and pharmacodynamic trials to confirmatory efficacy—will be required only as needed, based on the totality of evidence.
Once finalized, the guidelines will permit only minimal further changes, emphasizing the importance of thorough review during the comment period. By aligning with WHO and international frameworks, India aims to ensure that biosimilars reach patients safely, without compromising on innovation.
This draft marks a pivotal step toward strengthening India’s biosimilar ecosystem and securing affordable access to advanced therapies. Industry participants and public health advocates now have until June 5 to shape the final regulations that will guide India’s biologics industry for years to come.
