Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin (ingredient: bevacizumab), to the European Medicines Agency (EMA).

"We submitted the application after completing global clinical trials for a total of 689 patients at 164 sites in 21 countries since 2018," the company said. "We plan to obtain for all indications covered by Avastin, including metastatic colorectal cancer and non-small cell lung cancer."

The company stressed that it had also completed the approval application procedure in Korea and the U.S. and would apply for additional permits targeting major countries, such as Japan.

"Celltrion's strategy is to secure the sales license for CT-P16 for all indications first, and launch the treatment, a latecomer in the market, as soon as possible based on its competitive prices," the company said. "The substance patents for original drugs have expired in almost all countries. Therefore, once we receive the global approval for CT-P16, we will introduce the product in each market sequentially from the second half of next year."

CT-P16 will mark Celltrion’s third anticancer antibody biosimilar following Truxima, a blood cancer treatment, and Herzuma, a breast cancer treatment, establishing a strong portfolio in the difficult anticancer antibody treatment market, it added.

According to Celltrion, its anticancer antibody biosimilar products have a solid position in the advanced pharmaceutical market. Truxima and Herzuma account for 38.3 and 14.9 percent of the EU market in the first quarter of this year. In the U.S., Truxima has a market share of 26.9 percent.

Notably, Truxima has a market share exceeding that of the original product in Europe, and Herzuma maintains the leading position in market share in the European market among Herceptin biosimilars.

"Following Korea and the U.S., the approval process in Europe also began in earnest, expanding the company's anticancer drug portfolio," a company official said. "We will do our best to quickly supply high-quality anticancer antibody biosimilars by accelerating the approval process in close consultation with regulatory authorities."

Roche's Avastin, the original drug for CT-P16, 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 company, the global market for bevacizumab was estimated at 7.7 trillion won ($6.4 billion) last year.