Celltrion's Truffle Cure & Truxhima & # 39; will enter the US market. Celltrion is the second result after 2016, when it exceeded the US market threshold with "Ram シ ャ マ", autoimmune drugs.
Celltrion said on Tuesday that it had received approval from the US Food and Drug Administration (FDA) for the sale of biosimilar "Truxime" for the treatment of blood cancer.
According to Yonhap News, Truchshima is biosimilar for the treatment of non-Hodgkin's lymphoma, a type of blood cancer. The original remedy of Truxhima is Roche's Materia (Rituxan, the name of the ingredient: rituximab).
This is the first time that biosimilars of rituximab have been approved in the United States.
The US FDA has opened an advisory commission to approve the first biosimilian approval of a certain drug, and Truhima received a recommendation from the Advisory Committee last year. Celltrion Lamci (the American product name of Infractra) received the recommendation of the Advisory Board of Remicade Biomassilms in the United States in February 2016 and received final approval in April of that year.
This means that Celltrion got the first driver (market pioneer) status, which is the first biosimilar source drug in the United States, from Ramsay to Truxime.
In the biosimilar market, it is important that the first person takes over the first seat. First, it has many advantages that First Mover, the first to enter the market, dominates the market and takes over.
Celltrion also gives the impression that Truxhima has entered FirstMover on the largest US market. The US market for rituximab is about 5 trillion won, accounting for 56% of worldwide sales.
Celltrion said Truxham would be able to enjoy significant market barriers with First Mover in the United States, "he said." Our competitor Sandos gave up the US market for rituximab biosimilars, I hope to secure the position. "
Celltrion already increases its market share in Europe with Truxhim's first benefits.
Truxhima was first launched in the UK in April of the same year, after being licensed in Europe in February 2017 and expanding sales in 18 European countries since June 2018. According to the IQVIA Research Institute for Drug Market Research, Truhima's market share in the European market for rituximab is 32% since the second quarter of this year.
In the United States, Celltrion is a strategy of a fast strategy that takes advantage of the first driver and a favorable business environment without competition.
Teva, a multinational pharmaceutical company with North American rights, decided to sell Truxhime to the United States.
"We are pleased to be able to participate in biosimilar dealings with Truxhim's permission," said Brandon Ograditi, head of North America's business unit.
"We will continue to work to improve the quality of life of patients by providing biological benefits for treatment that are equivalent to those from original drugs," said Chung Woo Sung, Celltrion's director.