"Aiming for the 44 Trillion Won Market... Celltrion Applies for Approval of Keytruda Biosimilar"

Sequential Global Approval Applications in the US and Europe After Korea

Expanding Portfolio from Targeted Therapies to Immuno-Oncology Drugs

Celltrion has launched a full-scale effort to target the world’s largest pharmaceutical market, worth KRW 44 trillion in annual sales. The company has applied for domestic approval of its biosimilar version of the world’s top-selling immuno-oncology drug, Keytruda (ingredient: pembrolizumab), and plans to sequentially begin approval procedures in major markets such as the United States and Europe.

On August 24, Celltrion announced that it has submitted an application to the Ministry of Food and Drug Safety for product approval of its Keytruda biosimilar ‘CT-P51’. This application targets major indications of the original drug Keytruda, including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer. The application is based on clinical trial results conducted with 228 melanoma patients who underwent complete resection.

Aerial view of Celltrion Plant 2 in Songdo, Incheon. Photo by Hyunmin Kim

Through analysis of the clinical data, Celltrion demonstrated pharmacokinetic (PK) equivalence between CT-P51 and the original Keytruda. A comparison of the degree of drug exposure in the body showed both drugs met beforehand established equivalence criteria, and similar results were also confirmed in terms of safety and immunogenicity.

Keytruda is an immuno-oncology agent with indications for various types of cancer, such as non-small cell lung cancer and melanoma. As of last year, it ranked as the world’s top-selling pharmaceutical product, with global sales of approximately USD 31.7 billion (about KRW 44 trillion).

Starting with this domestic approval application, Celltrion plans to sequentially pursue approval procedures for CT-P51 in key global markets such as the United States, Europe, and Canada. The company’s strategy is to continue approval processes in major markets without delays, accelerate its entry into the global Keytruda market, maximize market share and profitability by joining the global first group of biosimilar competitors.

Previously, the company established its presence in the global oncology market by successfully launching targeted cancer therapies such as ‘Herzuma’ (ingredient: trastuzumab) for breast and gastric cancers, ‘Truxima’ (ingredient: rituximab) for hematologic cancers, and ‘Vegzelma’ (ingredient: bevacizumab) for metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, and various other types of cancer. With the addition of CT-P51, an immuno-oncology agent, Celltrion is rapidly building a robust oncology portfolio that encompasses both targeted therapies and immuno-oncology drugs.

In particular, because Keytruda and bevacizumab are co-administered in the treatment of ovarian and cervical cancers, Celltrion expects to further boost sales through synergies between CT-P51 and Vegzelma. In addition, the company plans to enhance profitability and expand market share over competitors by leveraging its large-scale in-house manufacturing facilities and direct sales networks in major global markets.

A Celltrion official stated, “Beginning in Korea, we will sequentially apply for approvals in key 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 reliable in-house production capabilities and a solid global direct sales network.”

This content was produced with the assistance of AI translation services.