Celltrion has submitted an application to obtain approval for CT-P16, a biosimilar of Roche's Avastin (ingredient: bevacizumab), for colorectal cancer treatment in the U.S. and Korea.

The company completed global clinical trials of CT-P16 at 150 cites in 20 countries in Europe, South America, and Asia and applied to both the U.S. Food and Drug Administration and the Korean Ministry of Food and Drug Safety to receive full approval for treating metastatic colorectal cancer and non-small cell lung cancer.

Celltrion also plans to receive authorization from Europe and other countries. The company explained that it could be introducing CT-P16 to the market from the second half of 2022 once it gets approved globally. The patent for original medicine has already expired in Korea, the U.S., and Europe.

When CT-P16 wins approval, Celltrion adds up its third anti-cancer biosimilar drug following Truxima for blood cancer Herzuma for breast cancer, securing a strong lineup in the difficult anticancer antibody treatment market.

Truxima has a market share that surpasses the original products in Europe, and Herzuma, a biosimilar of Herceptin, kept its top place in the European market.

Avastin, CT-P16's original model, is an anticancer drug used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma.

According to IQVIA, a drug market research firm, the global market for bevacizumab reached 7.7 trillion won ($6.05 billion) in 2020. The U.S. market accounted for about four trillion won, while the domestic market hovered around 120 billion won.

"As soon as we have completed clinical trials of CT-P16, we began preparing to apply for marketing approval in Korea and the U.S.," a Celltrion official said. "Starting with the application for domestic and the U.S. approval, we will speed up the regulatory process in Europe and other countries to supply quality anticancer biosimilar drugs to the global market."