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Home » Celltrion seeks US IND nod for Keytruda biosimilar phase III
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Celltrion seeks US IND nod for Keytruda biosimilar phase III

June 17, 2024
By Marian (YoonJee) Chu
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
BioWorld Regulatory Cancer Biosimilar U.S. FDA IND

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