Celltrion向EMA提交Cosentyx生物类似药CT-P55上市申请

Celltrion (068270.KS) has entered the European approval process for a biosimilar of Cosentyx (secukinumab), an autoimmune disease treatment. Following applications in Canada and Korea, the company has now filed for marketing authorization in Europe, part of a strategy to accelerate its push into the roughly 10 trillion won secukinumab market.
Celltrion said on the 24th that it has filed for marketing authorization with the European Medicines Agency (EMA) for its Cosentyx biosimilar "CT-P55." The application covers plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis — all indications for which Cosentyx has been approved in Europe. Celltrion previously demonstrated pharmacokinetic (PK) equivalence between CT-P55 and the original drug through clinical trials, and confirmed similarity in safety and immunogenicity.
CT-P55 is an autoimmune disease treatment that inhibits interleukin (IL)-17A, a protein involved in inflammatory responses. Cosentyx, the original drug, is a blockbuster product that recorded global sales of approximately $6.668 billion (about 10 trillion won) last year.
Celltrion filed its first marketing authorization application for CT-P55 in Canada in May, followed by an application in Korea in June. If the European approval process proceeds as planned, the company could launch the product among the first group in the secukinumab biosimilar market, giving it a first-mover advantage.
"The approval process for entering major global markets is now in full swing," a Celltrion official said. "We will swiftly establish a commercialization foundation with the goal of launching in the first group."