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Celltrion has been approved by the US Food and Drug Administration (FDA) for the sale of TRIXIMA, a rituximab biosimilator, and will enter the US $ 5 trillion KRW rituximab market. The United States is the largest market with 56% of world sales of rituximab. The approval of Trucushima also means that it has been approved by the FDA for the first time as a biosimilator of rituximab. As a result, Celltrion is expected to have significant pre-emptive market effects as a "First Mover" in the US market.
The biosimilars' Trucima & # 39; Celltrion's rituximab received marketing approval from the US Food and Drug Administration (FDA) on Wednesday, May 29. [AP=연합뉴스]
Trukshima is a biosimilar anti-cancer antibody used in the treatment of blood cancer, including "non-Hodgkin's lymphoma". It reproduces Roche's original drug "Mabtara", a global pharmaceutical company. MabThera is sold abroad under the name of Rituxan. Celltrion's biosimilars have been approved for sale in the United States for the second time since REMSIMA, a biosimilar antibody approved in April 2016. The sale of Trukshima to Europe has already been approved in February of the same year. last year and its first sale in the UK in April is in preparation with a 32% market share in the second quarter.
The reason why Trukshima's entry into the United States can be described as a "bloodless entry" is that its competitor, "SanDos", has given up its entry into the US market. This means that we will be able to preempt the US market without competitors at the moment. Trukshima will be sold in the United States through TEVA, a multinational pharmaceutical company with North American rights. "The US cancer field is more focused than ever on biosimilars," said Brandon Ogradide, North America Division Director. "We are excited to be able to participate in biosimilar activity with the permission of Truksima, I look forward to showing it early."
Celltrion's stock price jumped 4.66% to reach 247,000 won immediately after the US market opened. "The approval of Trucushima by the FDA will be a milestone for American patients who need a biosimilar treatment with rituximab," said Dr. Celltrion Koo Sung, Truchsoma's General Manager. "We offer therapeutic benefits equivalent to the original drugs, and I will do my best to improve the quality of life for patients."
Huh Jung Won reporter [email protected]
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