Celltrion Receives FDA Approval for Phase 3 Clinical Trial of Keytruda Biosimilar in the U.S.

Celltrion announced on the 12th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 3 Investigational New Drug (IND) application for 'CT-P51', a biosimilar to Keytruda (active ingredient: pembrolizumab).

Following this approval, Celltrion plans to conduct a global Phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer (NSCLC) to demonstrate the efficacy and equivalence of CT-P51 compared to the original drug, Keytruda.

Keytruda is an anti-cancer drug used to treat non-small cell lung cancer, gastric cancer, and head and neck cancer. Last year, it achieved global sales of approximately $25.11 billion (₩32.5143 trillion), making it the world's top-selling drug. The substance patent for Keytruda is set to expire in November 2029 in the U.S. and in January 2031 in Europe.

With the commencement of the global Phase 3 trial for CT-P51, Celltrion is expanding its oncology portfolio from targeted cancer therapies to immuno-oncology therapies. While targeted therapies selectively attack specific parts of cancer cells, immuno-oncology therapies utilize the body's immune system to eliminate cancer cells.

Celltrion has already launched three targeted cancer therapies: Herzuma(trastuzumab) for breast and gastric cancer, Vegzelma(bevacizumab) for metastatic colorectal cancer, and Truxima(rituximab) for hematologic malignancies. These therapies are expanding their market share in regions such as Europe, the U.S., and Asia. The company expects that the successful development of the immuno-oncology therapy CT-P51 will further strengthen its oncology portfolio.

A Celltrion representative stated, "We plan to proceed with the development of CT-P51 without any setbacks as part of our strategy to target the approximately ₩32 trillion ($25.11 billion) global market. We will continue to strengthen our portfolio across various therapeutic areas, aiming to obtain approval for 11 products by 2025."