This application covers the major indications of the originator drug Keytruda, including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer. It is based on clinical trial results from a study involving 228 melanoma patients who underwent complete resection.
Through analysis of the clinical data, Celltrion demonstrated pharmacokinetic (PK) equivalence between CT-P51 and the original drug Keytruda. A comparison of the extent of drug exposure in the body for both drugs showed that they met the pre-defined equivalence criteria, and similar results were confirmed regarding safety and immunogenicity.
Keytruda is an immuno-oncology drug used to treat various types of cancer, including non-small cell lung cancer and melanoma, and is the world’s top-selling drug, generating approximately $31.7 billion (about 44 trillion won) in sales last year. Given the overwhelming size of the market, it is expected to emerge as a key product that will drive Celltrion’s future revenue growth and profitability improvement.
Celltrion plans to sequentially submit regulatory applications for CT-P51, starting in South Korea and then moving on to major global markets such as the United States, Europe, and Canada. The company’s strategy is to proceed smoothly through the approval process to accelerate its entry into the global Keytruda market while also securing a position in the “First Group” to maximize market share and profitability.
The full-scale launch of the CT-P51 approval process is expected to serve as a turning point that will significantly advance the quality of Celltrion’s oncology business. The company has previously launched “Herjumma” (trastuzumab), a treatment for breast and stomach cancer; “Truxima” (rituximab), a treatment for blood cancers; “Vexzelma” (bevacizumab), used for various cancer types such as metastatic colorectal cancer, non-small cell lung cancer, and epithelial ovarian cancer—all of which are anticancer drugs that selectively target specific molecules—and has solidified its position in the global market. With the addition of CT-P51, an immunotherapy that activates the body’s immune system, the company is accelerating the development of a robust lineup of anticancer drugs that encompasses both targeted therapies and immunotherapies.
In particular, as the combination therapy of Keytruda and bevacizumab is being utilized for ovarian and cervical cancers—and as related indications are rapidly expanding—product synergies and sales growth between CT-P51 and Bevzelma are anticipated in the future. Celltrion plans to increase profitability and expand market share based on its large-scale in-house production facilities and direct sales networks established in major global markets.
Furthermore, CT-P51 is expected to generate future synergies with next-generation anti-cancer drugs, such as the antibody-drug conjugates (ADCs) currently under development. Through this, Celltrion intends to continuously expand the potential for synergy between biosimilars and innovative drugs.
A Celltrion official stated, “We plan to proceed smoothly with the approval process for CT-P51 to target the global Keytruda market, which is valued at approximately 44 trillion won,” adding, “Starting with South Korea, we will sequentially file for approval in major global markets such as the U.S., Europe, and Canada to secure a position among the global first-mover group. Based on our stable in-house production capabilities and robust global direct sales network, we will maximize synergies with our existing products and next-generation pipeline.”
