The US Food and Drug Administration (FDA) has approved Pyzchiva (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis Co., Ltd., for commercialization in the United States by Sandoz. This approval covers all indications of its reference medicine, including treatments for adults 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.
Pyzchiva will be available in several 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.
In addition to the approval, the FDA has granted a provisional determination for interchangeability for ustekinumab-ttwe, allowing it to be substituted for its reference product, Stelara.
Claire D’Abreu-Hayling, Chief Scientific Officer of Sandoz, highlighted the significance of the approval in a statement, saying, “This approval reflects our commitment to ensuring high-quality treatments are widely accessible. By expanding our immunology portfolio with affordable biosimilar alternatives, we are making significant progress towards our goal of providing life-changing medicines to patients in need.”
Leah Howard, JD, President and CEO of the National Psoriasis Foundation, underscored the impact of the approval, noting, “Systemic medications like biologics are crucial for many individuals managing symptoms of psoriasis and psoriatic arthritis. Unfortunately, barriers such as cost often hinder patient access to prescribed treatments. Psoriatic diseases require lifelong management, making the availability of FDA-approved options essential to improving healthcare affordability.”
Sandoz plans to launch Pyzchiva in the US market in February 2025, positioning it among the initial wave of ustekinumab biosimilars available in the country.
The FDA has previously approved two other biosimilars to ustekinumab, namely ustekinumab-aekn (Selarsdi) and ustekinumab-auub (Wezlana). Ustekinumab-aekn, developed by Alvotech and commercialized by Teva, received approval in April 2024 for use in adults and children aged 6 and older. Ustekinumab-auub was approved in October 2023.
Earlier this year, the FDA accepted Accord BioPharma’s Biologics License Application for DMB-3115, another proposed ustekinumab biosimilar expected to launch no later than May 15, 2025, pending FDA approval.
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