Celltrion announced on August 24 that it has submitted a marketing authorization application to South Korea’s Ministry of Food and Drug Safety for CT-P51, a biosimilar referencing the blockbuster immuno-oncology drug Keytruda.
Keytruda (active ingredient: pembrolizumab), developed by U.S. pharmaceutical company MSD, stands as the world’s top-selling prescription drug, generating global sales of approximately 44 trillion won ($31.7 billion) last year.
Celltrion demonstrated pharmacokinetic equivalence between CT-P51 and Keytruda in a clinical trial involving 228 patients who underwent complete surgical resection for melanoma. Based on these findings, Celltrion applied for marketing authorization across major indications, including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer. Given the originator drug’s market dominance, Celltrion expects CT-P51 to serve as a key driver of top-line revenue and long-term profitability.
Expanding Global Oncology Portfolio
The filing further strengthens Celltrion’s competitive lineup in the global cancer market. The company’s existing oncology portfolio includes Herzuma (trastuzumab) for breast and gastric cancer, Truxima (rituximab) for hematologic malignancies, and Vegzelma (bevacizumab) for metastatic colorectal cancer, non-small cell lung cancer, and epithelial ovarian cancer.
With combination therapies pairing bevacizumab and pembrolizumab expanding across clinical indications, Celltrion expects sales of Vegzelma and CT-P51 to reinforce each other.
Following its initial submission in South Korea, Celltrion plans to pursue regulatory filings sequentially in major international markets, including the United States, Europe, and Canada. The company aims to maximize commercial synergies by leveraging its in-house manufacturing infrastructure and global direct-sales network.
