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Biz News Korea(Eng)
Celltrion files for marketing approval of Herzuma in Japan
- Collected
- 2017.04.13
- Distributed
- 2017.04.17
- Source
- Go Direct
The Japanese market still has a high bar for the market entry by biosimilar manufacturers due to low preference among doctors and challenges of conducting clinical trials for local patients, the company said. Several companies are filing for marketing approval of their biosimilar drugs, but Celltrion’s Remsima to treat autoimmune disease is the only biosimilar licensed in Japan.
Herzuma is indicated to treat breast cancer and gastric cancer. Its reference drug is Herceptin developed by Genentech and marketed by Roche, and Herceptin sales in Japan are estimated to be 450 billion won ($398.4 million).
Herzuma will be distributed by Nippon Kayaku, the Japanese partner entitled to marketing exclusivity for Remsima and Herzuma in the country.
Nippon Kayaku well known for oncology drugs in Japan successfully launched Remsima in 2014 and has since raised its market share in Japan, Celltrion said.
Herzuma has already been filed for marketing approval in the EU and the result is expected to come as early in the third quarter of this year. Celltrion is soon to submit an NDA for the drug to the Food and Drug Administration (FDA) in the U.S.
At 1:15 p.m. in Seoul trading Thursday, shares of Kosdaq-listed Celltrion were down 0.2 percent at 89,900 won ($80).
By Shin Chan-ok
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