Celltrion Submits Joint Approval Applications in Korea and the US for Biosimilar of Anticancer Drug 'Avastin'

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Chunhee Lee] Celltrion's colorectal cancer treatment biosimilar 'CT-P16' (generic name 'Bevacizumab'), a biosimilar of 'Avastin,' is pursuing simultaneous approval in South Korea and the United States.

Celltrion announced on the 1st that it submitted a new drug application for CT-P16 to the U.S. Food and Drug Administration (FDA) on the 30th of last month. Following the submission of the approval application to the Korea Ministry of Food and Drug Safety on the 29th of last month, the company appears to be aiming for rapid market entry through simultaneous approval in both Korea and the U.S.

Since 2018, Celltrion has conducted global clinical trials involving 689 patients across more than 150 sites in over 20 countries in Europe, South America, and Asia. The company completed Phase 3 trials comparing the efficacy and safety of CT-P16 and Avastin as first-line treatments for metastatic or recurrent non-small cell lung cancer, and applied for approval to both agencies for all indications approved for Avastin, including metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, and cervical cancer. Celltrion plans to promptly submit approval applications to Europe and other major countries thereafter.

Avastin, developed by Roche, is an anticancer drug whose substance patent has expired in most countries worldwide, including South Korea, the U.S., and Europe. The global market size is estimated at approximately 7.7 trillion KRW, with 4 trillion KRW in the U.S. and 120 billion KRW in South Korea. Once the approval process for CT-P16 is completed, the product is planned to be sequentially launched in the market starting in the second half of next year.

With the approval and launch of CT-P16, Celltrion will secure its third anticancer antibody biosimilar following the existing blood cancer treatment 'Truxima' and breast cancer treatment 'Herzuma.' Celltrion's anticancer antibody biosimilars have established a solid position in advanced pharmaceutical markets, with Truxima achieving a 38.3% market share and Herzuma 14.8% in Europe during the first quarter of this year.

A Celltrion representative stated, “Immediately after successfully completing the global clinical trials for CT-P16, we have been preparing to submit marketing approval applications as quickly as possible in South Korea and the U.S. Starting with this approval application, we will accelerate submissions in Europe and other major countries and do our best to promptly supply high-quality anticancer antibody biosimilars globally.”

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