Celltrion Applies for European Approval of Biosimilar to Cancer Drug 'Avastin'

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 12th that it completed the marketing authorization application for the colorectal cancer treatment biosimilar 'Avastin (active ingredient: Bevacizumab)' biosimilar 'CT-P16' to the European Medicines Agency (EMA) on the 8th (local time).

Since 2018, Celltrion has completed global clinical trials involving a total of 689 patients at approximately 164 sites across 21 countries including Europe, South America, and Asia, and has submitted the marketing authorization application to the EMA for all indications approved for Avastin, including metastatic colorectal cancer and non-small cell lung cancer.

Celltrion previously completed marketing authorization applications with the Korea Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA). It also plans to proceed with applications in major countries such as Japan.

Celltrion's strategy is to first secure marketing authorization for CT-P16 for all indications and then quickly establish CT-P16 in the market as a latecomer by leveraging cost competitiveness derived from its own antibody drug development and manufacturing expertise.

The original drug's substance patents have expired in Korea, the U.S., Europe, and other regions, so once CT-P16's global approval process is completed, the product is planned to be sequentially launched in the market starting from the second half of next year.

Roche's Avastin, the original drug of CT-P16, is an anticancer agent used for treating metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma. As of 2020, the global market size for Bevacizumab was approximately 7.7 trillion KRW, with Europe accounting for about 2.2 trillion KRW.

A Celltrion official said, "Following Korea and the U.S., the approval process in Europe, a major biopharmaceutical market, is also accelerating, allowing us to expand our anticancer drug portfolio," adding, "We will work closely with regulatory authorities to speed up the approval process and do our best to promptly supply high-quality anticancer antibody biosimilars."