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Celltrion's "Trukshima" anti-cancer drug will enter the US market. Celltrion is the second result after 2016 after crossing the threshold of the US market with the "Ram ャ マ", a medicine against autoimmune diseases.
Celltrion announced Tuesday that it has received a marketing authorization from the US Food and Drug Administration (FDA) for the sale of a biosimilar "Truxima" for the treatment of blood cancer.
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According to Yonhap News, Truchshima is a biosimilar for the treatment of non-Hodgkin's lymphoma, a type of blood cancer. The original medicine of Trukshima is the Roche Materia (Rituxan, ingredient name: rituximab).
This is the first time that rituximab biosimilars are approved in the United States.
The US FDA has opened an advisory committee to approve the first biosimilar approval of a given drug. Truchima received a recommendation from the Advisory Committee last year. Celltrion's Lamcima (US product name Infractra) received a recommendation from the Remicade First Biosimilars Advisory Committee in the US in February 2016 and received final approval in April of the same year.
This means that Celltrion has acquired the status of First Mover (market pioneer), which is the first biosimilar of original medicines in the United States, from Ramshima to Trukshima.
In the biosimilar market, it is important for the first person to take their place. First, First Mover, which is the first to enter the market, has a lot of advantages in the market and prevents it.
Celltrion also gives the impression that Trukshima has entered FirstMover on the largest US market. The US rituximab market is worth about 5,000 trillion won, or 56% of total sales.
Celltrion said that "Trukshima will be able to benefit from a significant preemption from the market with Rituximab's First Mover in the United States." Competition, Sandos, has given up its entry into the US market of rituximab biosimilars, I hope to get a position. "
Celltrion is already increasing its market share in Europe with the first Trukshima advantage.
Trukshima was launched for the first time in the UK in April of the same year after being fired in Europe in February 2017 and has expanded its sales to 18 European countries as of June 2018. According to the research institute In the IQVIA market, Truchima's market share in the European rituximab market is 32% as of the second quarter of this year.
In the United States, Celltrion is a dynamic strategy in which the first-mover advantage and a favorable business environment without competition are established.
The sale of Trukshima in the United States was decided by Teva, a multinational pharmaceutical company with North American rights.
"We are delighted to be able to participate in the biosimilar trade with Trukshima's approval," said Brandon Ograditi, head of North America's commercial division.
"We will continue to work to improve the quality of life of patients by offering therapeutic benefits equivalent to those of the original drugs," said Chung Woo-sung, CEO of Celltrion.
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