Celltrion(068270) voluntarily withdrew the investigational new drug (IND) application and ended early the phase 3 trial in Europe for "CT-P51," which is being developed as a biosimilar of Merck (MSD)'s immuno-oncology therapy "Keytruda."
The company said on the 14th that it 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 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 "guidance on streamlined biosimilar development" that would allow skipping phase 3 if certain conditions are met. The European Medicines Agency (EMA) has also suggested that if equivalence is sufficiently demonstrated through quality analytics alone, a biosimilar may be approved without a phase 3 trial.
Accordingly, Celltrion adjusted its development strategy to reduce the number of trial subjects. A company official said, "Recruitment for the global phase 3 of CT-P51 has already been completed," and added, "With European Union (EU) countries excluded from the trial-participating countries, there is no longer a need to maintain the European study plan."
In countries other than the EU, the existing phase 3 trial 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 applied to the FDA to amend the study plan to reduce the phase 3 CT-P51 enrollment from the current 606 to 220.
Meanwhile, regulatory easing for biosimilars has also gained momentum in Korea. The Ministery of Food and Drug Safety announced a revision to the "Regulations on marketing authorization and review of biological products," allowing biosimilars that meet certain conditions to be approved without phase 3 data involving large numbers of patients.