Celltrion Receives Approval for Phase 3 Clinical Trial of Keytruda Biosimilar in Korea

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Celltrion announced on April 29 that its biosimilar of the immuno-oncology drug Keytruda, named CT-P51, has received approval from the Ministry of Food and Drug Safety to proceed with a Phase 3 clinical trial.

Keytruda is a blockbuster drug (with annual sales exceeding 1 trillion KRW) developed by the global pharmaceutical company Merck (MSD).

This clinical trial will be conducted to compare the efficacy and safety of CT-P51 and Keytruda.

The trial is expected to run for two years and will target approximately 600 patients with metastatic non-squamous non-small cell lung cancer who have not previously received treatment.

Celltrion stated, "We aim to demonstrate the similarity of CT-P51 to the original drug Keytruda in terms of efficacy and safety results."

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