US FDA resumes review of Celltrion's biosimilar Herzuma

By Yonhap
  • Published : Jun 18, 2018 - 14:19
  • Updated : Jun 18, 2018 - 14:38

Celltrion Inc., a South Korean biopharmaceutical firm, said Monday that the US Food and Drug Administration has resumed the review process for its biosimilar to treat breast cancer.

In May, Celltrion made a resubmission to the FDA to obtain marketing approval for Herzuma, a drug that was originally developed by Swiss pharmaceutical giant Roche Holding.

In accordance with FDA regulations, the approval procedure is forecast to be finalized within six months from the resubmission.

Global sales of the mega-hit Herceptin reached 7.9 trillion won ($7.1 billion) last year -- 3.48 trillion won in the United States alone.

FDA approval is forecast to help the local firm make further inroads in the global biosimilar market.

Herzuma, which was first launched in Britain, will further be rolled out in other European Union markets, including Italy, by the end of the second quarter. (Yonhap)