Home » India Spells Out Clinical Trial Conditions for Biosimilars Sponsors
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.
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