Celltrion has applied for domestic marketing approval for a biosimilar of MSD’s blockbuster immuno-oncology drug Keytruda, targeting a market worth KRW 44 trillion per year. The company plans to expand its oncology portfolio by adding an immuno-oncology agent to its existing targeted anticancer drugs, while sequentially pursuing approval procedures in key markets such as the United States and Europe to enter the global leading group.

Celltrion announced on the 24th that it has submitted a marketing authorization application to the Ministry of Food and Drug Safety for the Keytruda (ingredient name: pembrolizumab) biosimilar “CT-P51.”

The application covers Keytruda’s major indications, including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer. Celltrion submitted as the basis for the application clinical trial results from a study conducted on 228 melanoma patients who had undergone complete resection surgery.

According to the analysis of the clinical data, CT-P51 demonstrated pharmacokinetic (PK) equivalence to the originator drug Keytruda. A comparison of systemic drug exposure between the two products showed that the predefined equivalence criteria were met, and the company reported that similar results were observed for safety and immunogenicity.

Keytruda is a flagship immuno-oncology therapy developed and marketed by MSD, used in various tumor types such as non-small cell lung cancer and melanoma. Its global sales last year were approximately USD 31.7 billion, equivalent to about KRW 44 trillion. Intense competition among biosimilar manufacturers for the large market established by MSD through Keytruda is expected to unfold going forward.

Celltrion views this domestic marketing application as the first step toward entering the global market. Starting with Korea, the company plans to sequentially file for approval of CT-P51 in major markets including the United States, Europe, and Canada, with the aim of joining the “first group” in the global Keytruda biosimilar market.

If CT-P51 obtains approval, Celltrion’s oncology portfolio will expand from targeted therapies to include immuno-oncology agents.

Celltrion currently sells targeted anticancer biosimilars such as “Herzuma” (ingredient name: trastuzumab) for breast and gastric cancer, “Truxima” (ingredient name: rituximab) for hematologic malignancies, and “Vegzelma” (ingredient name: bevacizumab), which is used for metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, and other indications.

With the addition of CT-P51, which enhances immune responses against cancer cells by activating the patient’s immune system, the company will have both targeted anticancer drugs and immuno-oncology therapies. Celltrion expects this to broaden its product lineup in oncology and increase possibilities for linkage with existing products.

In particular, as Keytruda is administered in combination with bevacizumab for certain tumor types, Celltrion anticipates potential synergy between CT-P51 and its bevacizumab biosimilar Vegzelma. The company is also considering ways to link CT-P51 with next-generation anticancer drugs under development, such as antibody-drug conjugates (ADCs).

On the production and sales side, Celltrion will utilize its own manufacturing facilities and global direct sales network. In the biosimilar market, not only launch timing but also price competitiveness, supply stability, and local sales channels influence market share; the company plans to leverage its fully integrated structure from in-house production to sales to accelerate market entry.

A Celltrion official said, “To tap into the global Keytruda market valued at about KRW 44 trillion, we will proceed with CT-P51’s approval process without disruption,” adding, “Starting in Korea, we will sequentially pursue marketing applications in major global markets such as the United States, Europe, and Canada to join the global first group, and we will maximize synergies with existing products and our next-generation pipeline based on our in-house manufacturing capabilities and global direct sales network.”

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