Celltrion has submitted an application to the Ministry of Food and Drug Safety for approval of its biosimilar CT-P51, which targets the global blockbuster immunotherapy drug Keytruda (generic name: pembrolizumab).
On Monday, Celltrion announced that this application covers major indications of the original drug Keytruda, including non-small cell lung cancer, melanoma, gastric cancer, and head and neck cancer.
Celltrion conducted clinical trials on 228 melanoma patients who underwent complete resection. Through data analysis, the company demonstrated pharmacokinetic (PK) equivalence between CT-P51 and the original Keytruda. The comparison of drug exposure levels in the body met pre-established equivalence criteria, with similar results observed in safety and immunogenicity profiles.
Keytruda, an immunotherapy drug targeting various cancers including non-small cell lung cancer and melanoma, is projected to generate global sales of approximately 31.7 billion USD by 2025, making it the world’s top-selling pharmaceutical product.
Following this domestic approval application, Celltrion plans to pursue regulatory approvals for CT-P51 in key global markets, including the U.S., Europe, and Canada.
Celltrion is poised to strengthen its position in the global oncology market. The company has already successfully launched targeted cancer therapies such as Herzuma (trastuzumab) for breast and gastric cancers, Truxima (rituximab) for blood cancers, and Vegzelma (bevacizumab) for various cancers including metastatic colorectal cancer, non-small cell lung cancer, and epithelial ovarian cancer.
Notably, Keytruda and bevacizumab are being used in combination for ovarian and cervical cancers. As combination therapy indications rapidly expand, there are high expectations for synergies and increased sales between CT-P51 and Vegzelma.
Celltrion’s unique cost competitiveness, large-scale in-house production facilities, and robust direct sales network in key global markets position the company to achieve superior profitability and market share compared to competitors.
In the first half of this year, Celltrion reported record-breaking results with sales of 2.5387 trillion KRW (about 1.84 billion USD) and operating profit of 773.7 billion KRW (about 560 million USD). The company’s oncology portfolio continues to show strong performance globally. Vegzelma, in particular, has gained traction in major Asian markets, quickly achieving the top market share in Malaysia since its launch.
Celltrion is diversifying its growth strategy by expanding sales of existing biosimilars while bolstering its pipeline of follow-up products and novel drugs. The commercialization of CT-P51 is expected to significantly broaden the company’s oncology portfolio.
A Celltrion spokesperson stated that they’re committed to advancing the approval process for CT-P51 to target the 31.7 billion USD global Keytruda market. Starting with its domestic application, it will sequentially pursue approvals in major global markets including the U.S., Europe, and Canada, aiming to establish ourselves among the global leaders in this space.
