Sandoz obtains FDA nod for Stelara biosimilar
Sandoz has received the Food and Drug Administration’s permission for Pyzchiva (ustekinumab-ttwe), 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.
The medication is a biosimilar to Johnson & Johnson’s Stelara.
Developed by Samsung Bioepis, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the U.S. In addition, the FDA provisionally determined that Pyzchiva would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products.
Sandoz intends to launch Pyzchiva in the United States in February 2025, in accordance with the settlement and license agreement with Janssen Biotech. previously announced by Samsung Bioepi. Pyzchiva is expected to be among the first wave of ustekinumab biosimilars to launch in the United States.
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Claire D'Abreu-Hayling, chief scientific officer of Sandoz, said: “This approval reflects our dedication to ensuring high-quality treatments are universally accessible. 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.”
Pyzchiva is a key biosimilar value driver for the company over the mid-term, and this approval is a major step in advancing the Sandoz growth strategy by extending the U.S. immunology portfolio, Sandoz said.
Pyzchiva is approved by the FDA for all indications of the reference medicine Stelara (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, including to treat adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis.
Leah Howard, president and CEO of the National Psoriasis Foundation, said, "Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis. 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.”
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Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva in the U.S., Canada, the European Economic Area, Switzerland and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.