FDA Approves Biosimilar Ustekinumab-ttwe for All Indications of Reference Medicine

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The US Food and Drug Administration (FDA) has granted approval to Pyzchiva (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis Co., Ltd., to be commercialized by Sandoz in the United States.¹

The approval encompasses all indications of its reference medicine, including treatments for adult and pediatric patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.

The drug will be available in multiple forms: 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection, and a 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.

Additionally, the FDA has granted a provisional determination for interchangeability for ustekinumab-ttwe. This means that ustekinumab-ttwe can be expected to be substituted for its reference product, Stelara.

“This approval reflects our dedication to ensuring high-quality treatments are universally accessible," said Claire D'Abreu-Hayling, chief scientific officer of Sandoz, in a news release.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.”

Leah Howard, JD, president and CEO of the National Psoriasis Foundation, emphasized the significance of the approval.

"Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis," Howard said.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.”

Sandoz plans to launch ustekinumab-ttwe in the US in February 2025, positioning Pyzchiva to be among the first wave of ustekinumab biosimilars available in the US market.

The US FDA has also approved 2 other biosimilars to ustekinumab, including ustekinumab-aekn (Selarsdi) and ustekinumab-auub (Wezlana).

Developed by Alvotech and commercialized by Teva, ustekinumab-aekn was approved in April 2024 and can be used in adults and children aged 6 and older.² Ustekinumab-auub was approved in October 2023.³

Earlier this year, the FDA also accepted Accord BioPharma's Biologics License Application for DMB-3115, a proposed ustekinumab biosimilar. The proposed biosimilar is anticipated to launch no later than May 15, 2025, pending FDA approval.⁴

References

1. FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialized by Sandoz in US. News release. Sandoz. July 1, 2024. Accessed July 1, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/
2. Alvotech and Teva announce US FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab). News release. Teva. April 16, 2024. Accessed July 1, 2024. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-selarsdi-ustekinumab-aekn-biosimilar-to-stelara-ust
3. FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. FDA. October 31, 2023. Accessed July 1, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases
4. Accord BioPharma, Inc. Announces US FDA acceptance of Biologics License Application for proposed Stelara biosimilar DMB-3115. News release. Accord BioPharma. January 4, 2024. Accessed July 1, 2024. https://prnmedia.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-stelara-biosimilar-dmb-3115-302025983.html