Celltrion receives go-ahead for P3 study for Cosentyx biosimilar in US

Celltrion said it has obtained approval from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application to conduct a global phase 3 clinical trial for CT-P55, its Cosentyx (ingredient: secukinumab) biosimilar.

The global clinical trial will enroll a total of 375 patients with plaque psoriasis and aims to demonstrate the efficacy and safety equivalence between the original Cosentyx product and CT-P55.

Cosentyx is an interleukin (IL)-17A inhibitor developed by Novartis. The drug is used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate-to-severe plaque psoriasis. As of last year, Cosentyx generated approximately $4.98 billion in global sales, with its substance patent expected to expire in January 2029 in the U.S. and July 2030 in Europe.

Celltrion plans to continue strengthening its competitive edge in the autoimmune disease market by expanding its product portfolio from tumor necrosis factor-alpha (TNF-α) inhibitors to interleukin inhibitors.

The company aims to have a total of 11 biosimilar products by 2025 and expand its portfolio to 22 biosimilars by 2030, driving continued business growth.

"We are committed to building a robust portfolio in the autoimmune disease treatment sector, offering products that meet patient needs, from TNF-α inhibitors to interleukin inhibitors,” a Celltrion official said. “We will proceed with the phase 3 trials of CT-P55 and other pipeline products without delay, ensuring our continued growth in the biosimilar business."