Celltrion has applied for domestic approval of its biosimilar to the global blockbuster immuno-oncology drug Keytruda (ingredient: pembrolizumab), named CT-P51, as part of its strategy to strengthen its oncology portfolio. The company plans to expand into major markets such as the United States and Europe, starting with domestic approval.
On August 24, Celltrion announced that it submitted the application for the Keytruda biosimilar CT-P51 to the Ministry of Food and Drug Safety.
This application targets key 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 results from a study involving 228 patients with melanoma who underwent complete resection.
Keytruda is an immuno-oncology drug used for various types of cancer, recording approximately $31.7 billion in global sales last year, making it the highest-grossing drug worldwide.
Celltrion has demonstrated pharmacokinetic (PK) equivalence between CT-P51 and the original Keytruda through clinical data analysis. The comparison of drug exposure levels in the body met the pre-established equivalence criteria, and similar results were confirmed in terms of safety and immunogenicity.
Following this domestic approval application, Celltrion plans to sequentially pursue approval procedures in major global markets, including the United States, Europe, and Canada. This strategy aims to accelerate its entry into the global Keytruda market and maximize market share and profitability through First Group entry.
The company intends to enhance its oncology portfolio by adding CT-P51 to its existing targeted therapies, including Herjuda (ingredient: trastuzumab), Truxima (ingredient: rituximab), and Vegzelma (ingredient: bevacizumab). Notably, since Keytruda and bevacizumab are used in combination for the treatment of ovarian and cervical cancers, synergy between CT-P51 and Vegzelma is anticipated.
Additionally, CT-P51 is expected to synergize with next-generation cancer drugs currently under development, such as antibody-drug conjugates (ADCs).
A Celltrion official stated, "We will sequentially proceed with the approval process for CT-P51 to target the approximately $44 trillion global Keytruda market. We aim to expand synergies between existing products and next-generation pipelines based on stable production capacity and a global direct sales network."
Meanwhile, since 2019, when Seo Jung-jin, Chairman of Celltrion Group, proposed plans to establish a direct sales network overseas, the company has steadily built its direct sales system. Europe transitioned to a direct sales system in 2020, and the United States began direct sales in 2023.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.