Second Biosimilar of Stelara Launches

Teva Pharmaceuticals and Alvotech have launched Selarsdi (ustekinumab-aekn) in the United States. Selarsdi is a biosimilar that references Stelara (ustekinumab) to treat patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.

Selarsdi is interchangeable with Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025, according to a Teva news release. Selarsdi, approved by the FDA in October 2024, is available as a single-dose prefilled syringe for subcutaneous injection and in a single-dose vial for intravenous infusion.

Selarsdi is being offered at 85% off the wholesale acquisition cost of Stelara, and eligible patients may receive their medication at no cost or may be eligible for assistance through Teva’s programs, according to a company spokesperson. Teva is in ongoing discussions with payers about Selarsdi, but is unable to disclose details at this time.

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 Stelara list price $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. Eligible patients can get Stelara for $5 a dose through the savings program Stelara withMe.

Related: Wezlana, First Stelara Biosimilar To Hit the Market, Available Only Through Optum's Nuvaila

Selarsdi is the second Stelara biosimilar to launch. Amgen’s Wezlana (ustekinumab-auub) launched in January. Wezlana is available only through Optum, a division of UnitedHealth Group. An Optum spokesperson said in an email that Nuvaila has exclusivity to Wezlana. Nuvaila is a biosimilar procurement business similar to CVS Health’s Cordavis and Cigna/Express Scripts' Quallent.

A high- and low-list price version of the Stelara biosimilar has been available on Optum Rx’s commercial formularies since Jan. 1, 2025. Amgen offers a $0 copay program for commercially insured patients.

There are currently seven Stelara biosimilars that have been approved by the FDA. The others include Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Yesintek (ustekinumab-kfce), and Steqeyma (ustekinumab-stba), the last of which was approved at the end of December 2024.

The Stelara biosimilars that will launch this year will be launch closely. This is the first group of biosimilars whose reference product is part of the Medicare Drug Price Negotiation. Stelara was part of the first set of drugs to be negotiated through the program that is part of the Inflation Reduction Act. The new prices become effective January 2026.

When the new prices for these first 10 were released in August 2024, CMS said it had negotiated a price for Stelara that 66% less than the 2023 list price.

According to research report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE), which is part of the U.S. Department of Health and Human Services, Stelara had the second highest annual gross spending per Medicare enrollee. The report indicated that since its approval in 2009, Stelara’s price had increased about 184%. Additionally, average annual out-of-pocket spending per enrollee from 2018 to 2022 had the largest increase (190%), going from $709 per enrollee in 2018 to $2,058 in 2022.