On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. According to Sandoz, the PYZCHIVA® autoinjector “supports a more comfortable self-administration experience with accurate automatic dosing, less frequent injection pain, a compact design, and flexible storage options, offering the potential for improved adherence to patient treatment plans.” The autoinjector is currently available in Spain and “will continue to roll out across Europe.”
Sandoz and Samsung Bioepis entered into a development and commercialization agreement for an ustekinumab biosimilar in September 2023. Sandoz has the rights to commercialize PYZCHIVA® in the United States, Europe, Switzerland, the United Kingdom, and Brazil, and Samsung Bioepis has responsibility for development, registration, intellectual property, manufacturing, and supply.
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