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Biz News Korea(Eng)
Celltrion seeks EU agency approval to sell biosimilar on breast cancer treatment
- Collected
- 2016.11.01
- Distributed
- 2016.11.02
- Source
- Go Direct
The reference drug of Herzuma is Roche’s blockbuster breast cancer drug Herceptin (trastuzumab) which generated $6.8 billion in revenue last year.
The company conducted a large global clinical trial to meet the regulatory approval requirements from not only the EMA but also the US Food and Drug Administration. Its latest approval application is based on the successful results of the trial.
“Antibody biologic drugs to treat breast cancer are particularly more expensive than conventional anti-cancer drugs. We will try our best to receive regulatory approval of our biosimilars to bring benefits to more patients,” said Celltrion president Kim Hyung-ki.
Celltrion also plans to seek regulatory approval from the FDA to sell Herzuma in the United States
At 1:20 p.m., shares of Kosdaq-listed Celltrion were up 300 won at 106,500 won ($93.35).
By Shin Chan-ok
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