Celltrion(068270) voluntarily terminated the European phase 3 trial of "CT-P51," a biosimilar to Merck (MSD)'s immuno-oncology drug "Keytruda," and withdrew its investigational new drug (IND) application.
The company said on the 14th that it had notified the European Medicines Agency (EMA) of the early termination of the European phase 3 trial of CT-P51. The trial compares the efficacy and safety of CT-P51 with those of the original drug Keytruda in patients with previously untreated metastatic non-squamous Non-small cell lung cancer (NSCLC).
The decision is seen as reflecting a global trend of regulatory easing to streamline biosimilar development.
The U.S. Food and Drug Administration (FDA) recently released a draft "biosimilar development simplification guidance" that would allow skipping phase 3 under certain conditions. The European Medicines Agency (EMA) has also indicated that if equivalence is sufficiently demonstrated through quality analytics alone, biosimilars can be approved without phase 3 trials.
Accordingly, Celltrion adjusted its development strategy to reduce the number of trial participants. A company official said, "Recruitment for the global phase 3 trial of CT-P51 has already been completed," and added, "As European Union (EU) countries were excluded from the participating countries, there is no longer a need to maintain the European trial plan."
Outside the EU, existing phase 3 trials will continue. Celltrion plans to secure the data needed for approval in those countries by comparing the efficacy and safety of CT-P51 and Keytruda.
Earlier this month, Celltrion also filed an amendment to its investigational new drug application with the FDA to reduce the number of CT-P51 phase 3 participants from the original 606 to 220.
Meanwhile, regulatory easing for biosimilars has begun in Korea as well. The Ministery of Food and Drug Safety announced revisions to the "Regulations on approval and review of biological products," allowing biosimilars that meet certain conditions to be approved without phase 3 data in large patient populations.