Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Celltrion's Truxima granted for US sales
Celltrion's Truxima
By Nam Hyun-woo
By Nam Hyun-woo
Celltrion's biosimilar Truxima has received sales approval from the U.S. drug authority, earning early entry to the lucrative American market.
The drug maker said Thursday the U.S. Food and Drug Administration (FDA) approved Celltrion's Truxima, a monoclonal antibody biosimilar to Rituxan.
Rituxan was developed by Swiss pharmaceutical giant Roche to treat adult patients suffering from rheumatoid arthritis and non-Hodgkin's lymphoma, a type of leukemia.
Truxima is the first biosimilar to Rituxan in the U.S., and the company's second biosimilar to receive approval from the FDA, following Remsima.
“The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication,” Celltrion CEO Kee Woo-sung said.
“Truxima is the very first rituximab biosimilar to be approved in the U.S. for three non-Hodgkin's lymphoma indications and may help provide greater accessibility for patients.”
Analysts said Truxima will be a golden cash cow for Celltrion for a while, because the U.S. market for original Rituxan was valued at $4.2 billion last year, accounting for 55.9 percent of Rituxan's global sales.
Also, Celltrion's rival, Sandoz, recently announced it quit making a Rituxan biosimilar after the FDA requested more data, allowing Celltrion to enter the U.S. market without harsh competition.
“As Sandoz has called it quits, Truxima will secure an unrivaled status in the market, where early occupancy is very important,” KB Securities analyst Lee Tae-young said.
Truxima received approval in Europe in February last year and went on sale in the U.K. two months later. As of the second quarter of the year, it had a market share of 32 percent.
“The nearest rival for Truxima is a drug from Pfizer, which applied for FDA approval in September for its PF-05280586. Since approval is expected in the third quarter of 2019, Truxima will enjoy unrivaled status for at least seven months.”
Teva Pharmaceutical Industries will retail Truxima in the U.S. The two companies formed a partnership in October 2016 to commercialize the biosimilar in the U.S. and Canada.