REGULATORY REQUIREMENTS FOR BIOSIMILARS AS PER CDSCO IN INDIA IN COMPARISON WITH HEALTH CANADA

Dr. P. Ashok Kumar*, Anitha Patel, Mamata Vagaram Choudhary, Nithin K. M., Urja N.

ABSTRACT

This review examines the regulatory requirements for biosimilars in India and Canada, comparing the frameworks of the Central Drugs Standard Control Organization (CDSCO) and Health Canada. Biosimilars are biological medicines that are highly similar to an already-licensed reference biologic and offer a cost-effective alternative for the treatment of cancer, autoimmune disorders, diabetes and other chronic diseases. This comparative analysis reviews the manufacturing process, stepwise approval pathway, WHO guidelines, and the regulatory requirements followed by CDSCO in India and by Health Canada, including pre-licensing, licensing, manufacturing, pharmacovigilance, labelling, importation, marketing authorization, post-marketing surveillance, renewal and inspection requirements. Both CDSCO and Health Canada require a totality-of-evidence, comparability-based approach to demonstrate biosimilarity, but the two frameworks differ in their legal basis, reference-product requirements, registration fees, review timelines, and the extent to which comparative clinical efficacy studies may be waived. CDSCO has a dedicated Guideline on Similar Biologics and an abbreviated pathway relative to new biologics, whereas Health Canada authorizes biosimilars through a New Drug Submission supported by an eCTD dossier. The review also compares the biosimilar markets of the two countries, in which India has emerged as one of the largest biosimilar manufacturing and export hubs globally while Canada is one of the fastest-growing adopters of biosimilars in North America. The findings can inform regulatory agencies, manufacturers and researchers seeking to navigate biosimilar development and commercialization in these two markets.

Keywords: Biosimilars, Regulatory requirements, Health Canada, CDSCO, Clinical trials, Approval process.