Stelara Biosimilar Steqeyma Launches at 85% Discount

Celltrion has launched Steqeyma (ustekinumab-stba), its biosimilar of Stelara (ustekinumab), at list price at an 85% discount to the reference product. Steqeyma is available in both subcutaneous injection and intravenous infusion.

Stelara and its biosimilars treat patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis.

Stelara, developed by Johnson & Johnson, was originally approved by the FDA in 2009 for the treatment of adults with moderate to severe psoriasis. Stelara has a list price of $25,497.12 every 8 weeks for the 90 mg dose. In 2023, it generated $10.86 billion in global revenue, compared with $6.4 billion in 2022. In 2024, sales of Stelara declined 13.6% because of anticipated biosimilar competition, J&J executives said in a recent investor call.

Steqeyma was approved by the FDA in December 2024 based on the results of a phase 3 study that examined Steqeyma’s effectiveness to treat adults with moderate to severe plaque psoriasis. The study determined there are 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.

Celltrion offers several resources for patients, including a Patient Support Program and the CARES Co-pay Assistance Program, benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose.

Related: Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary

Navitus Health Solutions’ specialty pharmacy will offer a different biosimilar, an unbranded biosimilar of Stelara (ustekinumab), that the PBM estimates will save between $112,000 and $336,000 per patient per year compared with the annual per-patient cost of the reference product.

Lumicera Health Services has made a purchase agreement with Anda, a subsidiary of Teva Pharmaceutical, for a lower-priced biosimilar version of Stelara (ustekinumab). Under this agreement, Lumicera’s discounted net acquisition cost for the unbranded biosimilar (ustekinumab-aekn) is estimated to generate $120 million in annualized savings for clients.

Navitus will remove Stelara from its formulary on July 1, 2025.

Other Stelara biosimilars to have launched include Fresenius Kabi’s Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), which was developed by Samsung Bioepis and commercialized by Sandoz, and Biocon Biologics’s Yesintek (ustekinumab-kfce).

Pyzchiva will be available at a list price that is 80% below Stelara. Yesintek will have a wholesale acquisition cost (WAC) of approximately $3,000, reflecting about a 90% discount compared with Stelara’s WAC.

In January, Amgen’s Wezlana (ustekinumab-auub) launched. Wezlana is available only through Optum, a division of UnitedHealth Group. A high- and low-list price version of Wezlana has been available on Optum Rx’s commercial formularies since Jan. 1, 2025.