On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. The autoinjector is currently available in Spain and Sandoz will continue to roll it out across Europe.
The Pyzchiva® autoinjector is delivered through the Molly® platform of SHL Medical AG and is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.
Pyzchiva®, biosimilar to J&J’s Stelara® (ustekinumab), was developed and registered by Samsung Bioepis. Under a development and commercialisation agreement with Samsung Bioepis entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.
Pyzchiva® was first approved in Europe in April 2024 for treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis for patients aged 6 years and older. Sandoz launched Pzychiva® in Europe in July 2024 (as vial for infusion/PFS). Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths. In addition to the autoinjector, Pyzchiva® is available as a 130mg concentrate in a vial for solution for infusion, and a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.