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 wins sales approval for Humira biosimilar in Europe
A Celltrion plant in Cheongju, North Chungcheong Province / Courtesy of Celltrion
By Nam Hyun-woo
By Nam Hyun-woo
Celltrion said Monday it has won an (EMA) approval for CT-P17, a biosimilar to AbbVie's Humira, which is the top-selling drug in the world.
Celltrion obtained marketing authorization from the European Commission for CT-P17 on Feb. 11. CT-P17 will be marketed in the region under the name Yuflyma.
The green light came two months after the European Medicines Agency's Committee for Medical Products for Human Use recommended the authorization of CT-P17. The authorization covers all of Humira's target diseases including rheumatoid arthritis and inflammatory bowel disease.
CT-P17 is the first high-concentration biosimilar of Humira and provides pain-reducing features as it comes with a citrate-free formulation, meaning it causes less pain upon injection.
“Celltrion has been focusing on high-concentration type in developing CT-P17, and the authorization has recognized the distinguished competitiveness of this drug,” a Celltrion official said. “We will accelerate our distribution process to provide this high-quality biologic at a competitive price to patients and health workers in Europe.”
The company said its affiliate, Celltrion Healthcare, will be in charge of pricing of the drug for each country and finish other processes as soon as possible in order to take advantage of being the first high-concentration Humira biosimilar in the region.
“We aim to provide a wide range of anti-tumor necrosis factor treatment alternatives, together with Remsima for patients suffering from chronic inflammatory diseases,” the company said.
According to market tracker Evaluate, Humira was the top-selling drug in the world last year, achieving $19.83 billion in sales, but its growth has been slowing due to incoming biosimilars. Celltrion said it assumes more than 90 percent of Humira sold in Europe since 2015 is the high-concentration type.