Celltrion approved to initiate study for plaque psoriasis treatment in Japan

[Courtesy of Celltrion]

South Korean biopharmaceutical company Celltrion Inc. said Monday that it secured investigational new drug (IND) approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate phase 1 study for CT-P55, a biosimilar of plaque psoriasis treatment Cosentyx (secukinumab).

As part of Phase 1 clinical trial, Celltrion plans to assess the pharmacokinetics equivalence of CT-P155 to the reference secukinumab in 171 healthy Japanese adults.

Cosentyx, an interleukin (IL)-17 inhibitor developed by Swiss pharmaceutical company Novartis International AG, is used to treat patients with psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis,

The blockbuster generated an annual sales of about $4.7 billion in 2022. Its patent will expire in January 2029 in the United States and January 2030 in Europe.

While making further efforts to solidify its market share, Celltrion said its pipeline will be expanded to include TNF-α and IL inhibitors.

With the six bio medicines already being brought to the market, Celltrion will make sure to have five more new pipelines and CT-P55 developed and approved by 2025, the company said.