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Biz News Korea(Eng)
FDA accepts Celltrion’s BLA for breast cancer biosimilar
- Collected
- 2017.08.01
- Distributed
- 2017.08.02
- Source
- Go Direct
![[Photo by Celltrion]](http://file.mk.co.kr/meet/neds/2017/08/image_readtop_2017_515833_15015666482977399.jpg)
[Photo by Celltrion]
Herzuma is a biosimilar version of Roche`s blockbuster breast and gastric cancer treatment Herceptin (trastuzumab). Herceptin generates 7.9 trillion won ($7 billion) in global sales a year. Herceptin sales in the US alone were 3.48 trillion won last year.
As of 2:45 p.m., shares of Celltrion were down 1.2 percent at 107,200 won.
The Korean company said the application for marketing approval of Herzuma was filed in May and the FDA accepted the application after a 60-day review period under its rules, adding the approval is expected to come out until the first half of next year.
Israel-based Teva, the world`s largest generic pharmaceutical producer, will be responsible for the distribution of Herzuma and Truxima across the US.
"Herzuma has demonstrated safety and efficacy equivalent to its originator based on ample clinical data and study results were published in the Lancet, showing superiority to rival products,” said Celltrion president and CEO Kee Woo-sung, adding "we are committed to bring treatment benefits to more patients.”
Herzuma will also be launched in Korea late this year. Herzuma was approved by Korean health authorities in Jan. 2014 for the treatment of metastatic breast cancer, early stage breast cancer and metastatic gastric cancer. An application for marketing approval was also filed with the European Medicines Agency (EMA) last October and with the Ministry of Health, Labour and Welfare in Japan in April after a large-scale global clinical trial of patients with early stage breast cancer was completed.
By Shin Chan-ok
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