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Celltrion's biosimilar receives US FDA approval

Dec. 15, 2018 - 12:30 By Yonhap
Celltrion Inc.'s biosimilar to Roche's breast cancer treatment Herception has won approval from the US Food and Drug Administration, the South Korean drugmaker said Saturday. 

Celltrion's Herzuma is the biosimilar to Roche Holding AG's breast cancer treatment Herception, one of the world's most successful antibody medicines that raised $7.18 billion in sales in the United States in 2017. 

Teva Pharmaceutical Industries Ltd., a global pharmaceutical giant, will be in charge of its sales in the US market, Celltrion said. 

"Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy," Celltrion CEO Kee Woo-sung said.

(Park Hyun-koo/The Korea Herald)

"This is our second oncology biosimilar approval in the United States in the past month, which reinforces the goal for all of our approved products -- providing broader treatment options for patients and the providers who treat them." 

Herceptin, made of living cells, is used to treat patients with a certain type of breast cancer. (Yonhap)