미분류

Celltrion readies Herzuma for US market

By 황유미
  • Published : Sept 8, 2016 - 15:47
  • Updated : Sept 9, 2016 - 11:58

[THE INVESTOR] Celltrion has completed phase 1 of clinical trials in the US for Herzuma, its biosimilar replication of Herceptin, according to news reports on Sept. 8. 



Celltrion’s Herzuma, a breast cancer treatment, was approved by the Ministry of Food and Drug Safety in January 2014 and has finished international clinical trials, based on which it will file for European Medicines Agency’s endorsement within this year. 

To launch the biosimilar of Herceptin, the sixth most prescribed medicine in the world that raked in US$6.8 billion revenue in 2015, in the US, however, the South Korean pharmaceutical company has conducted a separate clinical trial in accordance with the requirements of US Food and Drug Administration.

By Hwang You-mee (glamazon@heraldcorp.com)