Payers Say They Are Planning to Add Stelara Biosimilars to Formularies

The beginning of the new year should see the start of the next wave of highly anticipated biosimilars: those of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.). While payers are saying they plan to have some of the biosimilars on formulary, many also say they will keep the reference drug on a preferred tier, according to Zitter Insights.

Stelara is approved for the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.

The interleukin-12/IL-23 antagonist is available in both subcutaneous and intravenous formulations. Most of the agent’s use is via subcutaneous injection, with intravenous infusions used only to initiate treatment for Crohn’s and ulcerative colitis before moving to subcutaneous dosing.

As of mid-December, the FDA has approved seven biosimilars of Stelara for all of the reference drug’s indications. Patent litigation with J&J has so far kept the competitors off the U.S. market, but settlements with various manufacturers have cleared the way for multiple launches in the first half of 2025.

Expected first is Amgen Inc.’s Wezlana (ustekinumab-auub), which is cleared to launch Jan. 1, 2025. The FDA granted the drug interchangeable status with Stelara. The Cigna Group’s Express Scripts and UnitedHealth Group’s Optum Rx already have revealed plans to add the agent to their formularies.

February looks to be a busy month, with Alvotech and Teva Pharmaceutical Industries Ltd. affiliate Teva Pharmaceuticals, Inc.’s Selarsdi (ustekinumab-aekn) able to launch Feb. 21, 2025. Three other biosimilars are cleared to launch the following day: Biocon Ltd subsidiary Biocon Biologics Ltd’s Yesintek (ustekinumab-kfce), Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz) and Samsung Bioepis Co., Ltd. and Sandoz’s Pyzchiva (ustekinumab-ttwe), which has provisional interchangeability due to an “unexpired period of exclusivity for the first interchangeable biosimilar.” Celltrion USA, Inc. has said that Steqeyma (ustekinumab-stba), approved Dec. 17, also is cleared to launch in February.

Intas Pharmaceuticals, Ltd. division Accord BioPharma, Inc. has said that its Imuldosa (ustekinumab-srlf) can launch May 15, 2025.

Still pending at the FDA is an application for Hikma Pharmaceuticals PLC and Bio-Thera Solutions, Ltd.’s BAT2206. Bio-Thera has applied for interchangeability status for BAT2206; it is unclear when the agent might launch.

In its Biosimilars Landscape report, published May 8, 2024, Cardinal Health lists two additional agents in clinical trials: NeuLara from NeuClone Pharmaceuticals Ltd and BFI-751 from BioFactura, Inc., the latter of which will be commercialized by CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, the companies said in July 2023.

For the Managed Care Biologics and Injectables Index: Q2 2024, from May 20, 2024, to June 9, 2024, Zitter Insights polled 35 commercial payers covering 116.5 million lives, 29 Medicare payers covering 43.3 million lives and 51 physicians about their current and anticipated management and prescribing of biosimilars.

AIS Health and Zitter Insights are both divisions of MMIT.

Payers covering 42% of commercial lives said they expect to have two IL-12/IL-23 antagonists on formulary in the next two years, while those with 41% of lives said three. Payers representing 67% of commercial lives said they expect to include Stelara on their 2025 formulary, and of those respondents, payers with 45% of covered lives said they expect the reference drug to be on the preferred brand tier, while those with 24% of lives said that a decision on that had yet to be made.

Among the 49% of physicians who had prescribed Stelara within the past six to 12 months, the top factors in their decision to prescribe a biosimilar were that it be a similar formulation to the reference product and that it have interchangeability status. Payers covering commercial lives also cited interchangeability, as well as that the biosimilar have all the dose presentations of the reference drug (see infographic).