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Biz News Korea(Eng)
Celltrion’s Truxima biosimilar available across Europe upon final nod from EU commission
- Collected
- 2017.02.22
- Distributed
- 2017.02.24
- Source
- Go Direct
At 2:00 p.m. in Seoul trading Wednesday, the Kosdaq-listed shares of Celltrion was up 0.8 percent at 101,800 won ($89).
The approval is based on data from various studies that showed Truxima is bioequivalent to its reference drug Rituxan in safety and efficacy, the company said in a disclosure statement.
The EC’s approval is equally effective in 28 European Union members and three European Economic Area countries - Norway, Iceland and Lichtenstein.
The approval for Truxima is applied to all indications of Rituxan under the extrapolation method, which include non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis, the company said.
Truxima was approved in Korea last November. The manufacturer aims to submit a New Drug Application (NDA) with the U.S. counterpart FDA in the first half of this year.
The company said that the approval reaffirms its vision to play as a first mover in the European market, which represents 45 percent of global Rituxan sales.
By Kim Hye-soon
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