India Spells Out Clinical Trial Conditions for Biosimilars Sponsors

To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials.

However, trials may be waived when all of the following conditions are met:  

• Structural and functional comparability of a biosimilar and the reference product can be characterized to a high degree of confidence by physicochemical and in vitro techniques;
• The biosimilar is comparable to the reference product in all preclinical evaluations conducted;
• The PK / PD study has demonstrated comparability and has been conducted in an in‐patient setting with safety measurements, including immunogenicity; and
• A comprehensive postmarketing risk management plan has been presented that will gather additional safety data with a specific emphasis on gathering immunogenicity data.