Celltrion announced on the 12th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for CT-P51, a biosimilar of the immuno-oncology drug Keytruda, currently under development.
With this approval, Celltrion plans to conduct a global Phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer to demonstrate the efficacy and equivalence between the original drug Keytruda and CT-P51.
Keytruda is an immuno-oncology drug used to treat non-small cell lung cancer, gastric cancer, head and neck cancer, among others. It is a blockbuster drug that ranked first in global pharmaceutical sales last year with $25.011 billion (approximately 34 trillion KRW) in revenue. Its substance patent is expected to expire sequentially, in the U.S. by 2029 and in Europe by 2031.
Celltrion explained that with CT-P51 entering the full-scale global Phase 3 clinical trial process, it has expanded its oncology portfolio beyond the existing targeted therapies. While existing targeted therapies selectively attack specific parts of cancer cells, immuno-oncology drugs utilize the body's immune system to eliminate cancer cells. Celltrion currently holds three targeted oncology drugs: Herzuma, Vegzelma, and Truxima.
A Celltrion representative said, “We will proceed with the development of CT-P51 without delay to prepare for the global market entry of Keytruda. We will continue to strengthen our portfolio across various therapeutic areas and aim to obtain approval for 11 biosimilar products by next year, dedicating ourselves to securing future growth engines.”
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