Celltrion's Steqeyma nabs FDA approval as seventh Stelara biosimilar

Key takeaways:

• The FDA approved Steqeyma as the seventh Stelara biosimilar with an expected launch date of February 2025.
• Steqeyma’s indications match the reference product.

The FDA has approved the Stelara biosimilar Steqeyma for the treatment of adults and children with plaque psoriasis and psoriatic arthritis and adults with Crohn’s disease and ulcerative colitis, Celltrion announced in a press release.

“Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients,” Mark G. Lebwohl, MD, dean of clinical therapeutics and chair emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine at Mount Sinai, said in the release. “The approval of new treatment options is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the U.S. adult population.”

Administered via subcutaneous injection or intravenous infusion, Steqeyma (ustekinumab-stba, Celltrion) is now the seventh biosimilar for Stelara (ustekinumab, Janssen). Ustekinumab, a fully human monoclonal antibody, selectively inhibits both interleukin-12 and IL-23 — key drivers of inflammation — making it a welcome treatment option for patients living with these diseases.

According to the release, this recent approval was supported by “the totality of evidence,” including results from a phase 3 plaque psoriasis study in which Steqeyma and Stelara demonstrated results that were clinically similar in safety and efficacy.

The approval follows that of Yesintek (ustekinumab-kfce, Biocon), the sixth Stelara biosimilar, earlier this month. Like Yesintek, Steqeyma will not be released in the U.S. until February 2025. In fact, due to settlement and license agreements, no biosimilar are licensed to be released in the U.S. until 2025, meaning clinicians can expect an influx of Stelara biosimilars in the coming year.