Ustekinumab-ttwe Receives FDA Approval as New Stelara Biosimilar

Credit: US Food and Drug Administration

Sandoz has announced the US Food and Drug Administration (FDA) approval of the ustekinumab (Stelara) biosimilar ustekinumab-ttwe (Pyzchiva) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.¹ Additionally, the FDA has permitted provisional determination for interchangeability designation for the biosimilar.

The approval encompasses all indications of the reference product, including for the treatment of active psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), pediatric (aged 6 years or older) moderate to severe plaque PsO, and moderate to severe active Crohn’s disease and ulcerative colitis.¹

"Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis,” said Leah M Howard, JD, President and CEO of the National Psoriasis Foundation.¹ “Unfortunately, barriers to care, including costs, often prevent patients from getting the drug they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-term treatment costs. Having more FDA-approved options can help make appropriate healthcare more affordable.”

The approval was based on clinical data that showed ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, demonstrated similar safety and efficacy compared with the reference product. These include a randomized, double-blind, 3-arm phase 1 trial that reported comparable pharmacokinetics and immunogenicity, as well as a phase 3 clinical study that showed similar results up to week 28 among patients with moderate to severe plaque psoriasis.^2,3

“This approval reflects our dedication to ensuring high-quality treatments are universally accessible,” said Claire D'Abreu-Hayling, Chief Scientific Officer, Sandoz.¹ “By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards achieving our goal of delivering life-changing medicines to the patients who need them.”

The biosimilar is expected to launch in the US in February 2025.¹

References

1. ^{FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sandoz.com. July 1, 2024. Accessed July 1, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/.}
2. ^{A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects. Clinicaltrials.gov. April 5, 2022. Accessed July 1, 2024. https://clinicaltrials.gov/study/NCT04772274.}
3. ^{A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis. Clinicaltrials.gov. December 19, 2022. Accessed July 1, 2024. https://clinicaltrials.gov/study/NCT04967508.}