Celltrion applies for domestic approval of Keytruda biosimilar

Celltrion has applied for domestic marketing authorization from the Ministry of Food and Drug Safety for CT-P51, a biosimilar of the global blockbuster immunotherapy drug Keytruda (pembrolizumab). The application covers major indications including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer.

Clinical data from 228 melanoma patients who underwent complete resection demonstrated pharmacokinetic equivalence between CT-P51 and the original drug, with similar results in safety and immunogenicity. Keytruda is a leading immunotherapy with global annual sales reaching approximately $31.7 billion.

Following the domestic application, Celltrion plans to sequentially seek regulatory approval in major global markets, including the United States, Europe, and Canada, aiming to enter the ‘First Group’ of biosimilars. The company intends to leverage its existing oncology portfolio—which includes Herzuma, Truxima, and Vegzelma—to create synergies, particularly through combination therapies for ovarian and cervical cancers.