Celltrion seeks sales approval for anticancer biosimilar in Europe

By Shim Woo-hyun
  • Published : Oct 12, 2021 - 20:44
  • Updated : Oct 12, 2021 - 20:44

Celltrion`s headquarters in Songdo, Incheon (Park Hyun-koo/The Korea Herald)

South Korean drugmaker Celltrion said Tuesday that the company has submitted an application to the European Medicines Agency for approval of the sale of its anti-cancer biosimilar candidate CT-P16.

CT-P16 is a biosimilar of Roche’s Avastin, an anti-cancer treatment that kills cancer cells by preventing the growth of blood vessels. Avastin, which can treat numerous cancers, including metastatic colorectal cancer, has been Roche’s bestselling cancer drug.

The patents on Avastin, however, expired in the US in 2019 and will expire in Europe in January 2022.

Celltrion said it plans to seek regulatory approval in major markets with an aim of launching the drug candidate starting in 2022.

The firm, which is awaiting sales approval from the US Food and Drug Administration, added it will take the same process in Japan as well.

If approved, the biosimilar of Roche’s blockbuster pill is expected to help Celltrion boost its earnings.

Last year, Avastin posted $6.4 billion in global sales. In the European market alone, Roche’s anti-cancer drug secured $1.8 billion in sales.

Celltrion started global clinical trials of CT-P16 in 2018, involving 689 participants at 164 medical institutions in 21 countries.

If successfully launched, CT-P16 will become Celltrion’s third anti-cancer biosimilar, following Truxima and Herzuma.