On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation on Approval and Review of Biological Products. The revisions permit Phase 3 clinical trial data to be waived for biosimilar approval applications if equivalence with the reference drug is sufficiently demonstrated through quality, non-clinical, and pharmacokinetic studies.
The change is aimed at accelerating biosimilar development and aligning Korean regulations with global standards. The European, US and Canadian regulatory agencies have adopted similarly reduced requirements for Phase 3 clinical trial data, as follows:
- At its meeting from 23-26 March 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a reflection paper which considers that, in certain circumstances, analytical comparability and pharmacokinetic data may be sufficient for approval of biosimilars, with Phase 3 trial data no longer required;
- On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost of medicines for consumers. In the new draft guidance, FDA “recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified” stating that “this change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.”
- On 19 May 2026, Health Canada published its revised Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs, providing that comparative clinical efficacy studies are not typically required for a biosimilar to a Canadian reference biologic drug when the biosimilar has been compared and extensively characterised by analytical and clinical pharmacology studies.
Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Celltrion streamlining its US Phase 3 trial for biosimilar pembrolizumab and EU Phase 3 biosimilar secukinumab trial, Sandoz streamlining its nivolumab and ocrelizumab biosimilar trials and minimising its Phase 3 biosimilar pembrolizumab trial, and Formycon voluntarily terminating its Phase 3 clinical trial for biosimilar pembrolizumab.