Celltrion is slated to initiate the phase 1 clinical trials of its biosimilar referencing Roche’s blockbuster cancer drug Avastin in South Korea as the trials were officially approved by local regulators on Monday.

Korea’s Ministry of Food and Drug Safety has granted Celltrion approval to start phase 1 trials of its biosimilar referencing Avastin, developed by Roche-owned Genentech for the treatment of various cancers including colorectal cancer and lung cancer.

The trials, to be conducted at three local hospitals, will compare the effectiveness of Avastin with CT-P16, a biosimilar copy of Avastin developed by Celltrion.

The drugmaker is aiming to file its Avastin biosimilar to the Korean drug regulator for approval next year.

CT-P16 marks Celltrion’s third biosimilar referencing blockbuster therapies for cancer. The firm has already developed biosimilars referencing Herceptin and Rituxan. 

Its Rituxan biosimilar has already hit markets in Europe while its Herceptin biosimilar is awaiting approval by the European drug regulator. Both drugs have been commercialized in Korea.

Based in Songdo of Incheon, Celltrion also currently sells biosimilars referencing Remicade in the US via Pfizer and in Europe via multiple global marketing partners including Mundipharma and Biogaran.

By Sohn Ji-young (jys@heraldcorp.com)