Celltrion셀트리온 Inc. has launched its biosimilar to treat hematologic malignancy, Truxima, in Germany, following Korea and the United Kingdom, the company said Thursday.
The European Medicines Agency (EMA) approved Celltrion's application in February to sell the antibody biosimilar Truxima, used for treating non-Hodgkin's lymphoma and rheumatoid arthritis, a type of blood cancer, it said.
|Celltrion’s biosimilar Truxima has started to hit the German shelves, securing a marketing beachhead to advance the 28-nation European Union.|
Truxima’s reference drug, Roche’s blockbuster lymphatic cancer treatment Rituxan, is generating sales of more than 7 trillion won ($6.2 billion) a year.
Germany is the world’s second-largest market for original medicine and is one of the regions to which the Korean medical community has paid close attention concerning the launch of Truxima.
Mundipharma International began to release a large volume of the biosimilar product on a wholesale basis in the European country in May, and plans to complete the launch in most European countries by the second half of this year, Celltrion said.
"Through continuous clinical trials, we have proved that the biosimilar is equivalent to the original drug in efficacy and safety, and are speeding up global launching based on our success in Korea, the U.K., and Germany,” a Celltrion official said. "We plan to complete the launch of Truxima in most of the European countries this year, with the goal of preempting the market share to the maximum ahead of the latecomers."
With the EMA approval, the Korean company expects to sell the product in all 28 European Union member countries, including Norway, Iceland, and Lichtenstein.
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