Updated: Two More Stelara Biosimilars Launch

Sandoz and Biocon Biologics have each launched their biosimilar versions of Johnson & Johnson’s Stelara (ustekinumab).

Pyzchiva (ustekinumab-ttwe), developed by Samsung Bioepis and commercialized by Sandoz, is expected to be interchangeable in the first half of 2025. Both Pyzchiva and Biocon Biologics’s Yesintek (ustekinumab-kfce) treat patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Both biosimilars are available in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL single-dose vials for intravenous injection, and 45 mg/0.5 mL subcutaneous single-dose vials.

Pyzchiva will be available at a list price that is 80% below the current Stelara list price, which is $25,497.12 every 8 weeks for the 90 mg dose.

A spokesperson for Sandoz said the company is working with payer customers to secure access for patients. “Sandoz is confident in being positioned favorably on payer formularies but will not discuss specifics until payers officially announce their formularies,” the spokesperson said.

Yesintek will have a wholesale acquisition cost (WAC) of approximately $3,000, reflecting about a 90% discount compared with Stelara's WAC, making it the lowest-priced ustekinumab biosimilar. A Biocon Biologics spokesperson said the company has had productive discussions with many payers, and they anticipate formulary announcements through March and April.

"Many payers have shown strong interest in Biocon Biologics’ biosimilar ustekinumab, and we have been actively engaged in discussions regarding coverage," the spokesperson said. "With Biocon’s Biologics vertical integration and manufacturing we are well positioned to win payer coverage. We believe our approach creates a roadmap to success and we are seeing commercial agreements follow, including some that are exclusive to the company."

Sandoz and Biocon have indicated they are providing support resources for patients, including $0 copay programs for eligible patients. The terms of both Pychiva and Yesintek copay programs say the copay assistance is not available when accumulator adjustment or maximizer programs are applied.

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.

Pyzchiva, approved in July 2024, was approved based on the totality of the evidence. This includes a single-dose phase 1 clinical study that demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity in healthy volunteers and a phase 3 confirmatory study in patients with moderated to severe plaque psoriasis. The phase 3 study showed the same efficacy between Pyzchiva and Stelara at week 12 and up to week 28. The results of the phase 3 study was published in the Journal of the American Academy of Dermatology and were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024.

Yesintek, approved in December 2024, was shown to be comparable to Stelara in treating patients with moderate to severe plaque psoriasis. Clinical efficacy was maintained for patients who continued with Yesintek, as well as for those who switched from Stelera to Yesintek after week 16, according to company data.

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

Two additional Stelara biosimilars have already launched. Last week, Teva and Alvotech it’s biosimilar Selarsdi (ustekinumab-aekn) at an 85% discount off Stelara, and eligible patients may receive their medication at no cost or may be eligible for assistance through Teva’s programs 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.

In January, Amgen’s Wezlana (ustekinumab-auub) launched in January. Wezlana is available only through Optum, a division of UnitedHealth Group. A high- and low-list price version Wezlana has been available on Optum Rx’s commercial formularies since Jan. 1, 2025. Amgen offers a $0 copay program for commercially insured patients.

This story has been updated to include additional information about Yesintek's pricing.