MedImpact To Offer Unbranded Ustekinumab-aekn Biosimilar

MedImpact Holdings Inc. is planning to release a Stelara (ustekinumab) biosimilar, according to a recent news release.

The unbranded ustekinumab-aekn biosimilar will be available for purchase from Birdi, Inc. by any licensed specialty pharmacy at a rate of 95% less than Stelara, the news release says.

Anda, a Teva Pharmaceuticals USA affiliate, will distribute it. It is expected to be available January 1, 2026.

This announcement is part of MedImpact’s broader plan to enhance price transparency and reduce the industry’s reliance on rebates, the news release says. Private-label versions sold by other PBMs are available exclusively through the pharmacies that they own.

“MedImpact’s specialty strategy is deeply rooted in the principle that pharmacies, members, and payers should not have to compromise access for affordability, and this strategy delivers on that promise,” Arpit Patel, MedImpact Senior Vice President of Trade Relations and Supply Chain, said in the news release.

Although immune-mediated inflammatory conditions affect approximately 50 million Americans, the cost of biologic therapies remains a significant barrier for some.

In 2023, biologic drugs made up only 2% of all prescriptions but accounted for 46% of drug spending in the United States. Biosimilars cost approximately 50% less than their biologic reference products and are projected to save $181 billion in the next five years, according to an analysis by Kaiser Permanente.

Immune inflammatory conditions are often lifelong, and without treatment, patients can face disability, increased hospitalization and reduced quality of life.

The biologic, Stelara, was first approved by the FDA in 2009 for adults with moderate to severe plaque psoriasis. It currently has eight biosimilars across multiple indications for both adult and pediatric patients, including moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

The current list price of Stelara is $25,497.12 every eight weeks for the 90 mg dose. Some privately insured patients can pay as little as $5 using Stelara assistance programs, but these savings do not apply to patients using Medicaid, Medicare or other government-funded programs to pay for their medication.

“Today, a drug’s cost rises at each step in the supply chain,” Patel said. “We designed our unbranded strategy to bypass these costs to deliver far greater value to pharmacies and payers and a more affordable treatment option for patients.”

Starjemza (ustekinumab-hmny) is the most recent Stelara biosimilar, approved by the FDA in May 2025. It is preceded by:

• Steqeyma (Ustekinumab-stba) approved in December 2024
• Yesintek (ustekinumab-kfce) approved in November 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

The patents for Stelara expired in September 2023, which led to this influx of biosimilars.

Imuldosa announced earlier this week the availability of prefilled syringes at a 92% discount and vial formulation at a 30% discount from Stelara. It currently is the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars.

Because all Stelara biosimilars are immunosuppressants, there is an increased risk of certain infections such as diverticulitis, pneumonia and listeria meningitis when taking them.