Celltrion Receives Approval in Japan for Phase 1 Clinical Trial of Cosentyx Biosimilar CT-P55
Celltrion announced on Dec. 18 that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for a Phase 1 clinical trial plan (IND) for CT-P55, a biosimilar of the psoriasis treatment Cosentyx (active ingredient: secukinumab).
CT-P55 is a new autoimmune disease biosimilar pipeline of Celltrion. The company plans to conduct a Phase 1 clinical trial involving 171 healthy Japanese adults to compare the pharmacokinetic (PK) equivalence between Cosentyx, which is approved in Europe and the United States, and CT-P55.
With this clinical trial, Celltrion is set to commence clinical trials of the interleukin (IL)-17A inhibitor CT-P55, following its IL-12, 23 inhibitor Stelara biosimilar (CT-P43). The company aims to continuously expand its portfolio in the autoimmune disease treatment domain, from tumor necrosis factor alpha (TNF-α) inhibitors to interleukin inhibitors, to strengthen its market competitiveness.
Source:- BusinessKorea