FDA Approves Seventh Stelara Biosimilar, Steqeyma

The FDA has approved Celltrion’s Stelara biosimilar Steqeyma (CT-P43), for adult and pediatric patients with plaque psoriasis and active psoriatic arthritis as well as adults with Crohn’s disease and ulcerative colitis, according to a recent news release. Steqeyma is expected to be available in the United States in February 2025.

This approval is based on the results of a phase 3 study that examined Steqeyma’s effectiveness to treat adults with moderate to severe plaque psoriasis. Success was measured using the Psoriasis Area and Severity Index. The study determined there is no clinical or safety differences between Steqeyma’s and its reference product, ustekinumab. The most common adverse reactions occurring in at least 3% of patients were nasopharyngitis, vomiting and headaches.

Steqeyma is a fully human monoclonal antibody, an artificial antibody designed to stimulate the immune system to fight inflammation, according to the National Cancer Institute. Autoimmune induced inflammation is a key symptom in the listed indications.

“Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients,” said Mark G. Lebwohl, M.D., from the Icahn School of Medicine at Mount Sinai, New York and Celltrion consultant. “The approval of new treatment option 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.”

Steqeyma will be available in both subcutaneous and intravenous formulations in multiple strengths. The subcutaneous formulation comes in a 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and the intravenous formulation is available as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.

In addition to Steqeyma, the other Stelara biosimilars are:

• Yesintek (ustekinumab-kfce) approved in December 2024
• Imuldosa (ustekinumab-srlf) approved in October 2024
• Otulfi (ustekinumab-aauz) approved in September 2024
• Pyzchiva (ustekinumab-ttwe) approved in June 2024
• Selarsdi (ustekinumab-aekn) approved in April 2024
• Wezlana (ustekinumab-auub) approved in October 2023

Stelara was originally approved by the FDA in 2009 for the treatment of adults with moderate to severe psoriasis.

Stelara is an expensive drug with list price of $13,836 for one month supply. In 2023, it generated $10.86 billion in global revenue, compared with $6.4 billion in 2022. Eligible patients can get Stelara for $5 a dose through the savings program Stelara withMe.

Starting in 2026, under the Inflation Reduction Act, Medicare members will be able to get a 30-day supply of Stelara for 66% off list price, costing $4,695.