Sandoz unveils biosimilar Pyzchiva across Europe to treat chronic inflammatory diseases

“The launch strengthens our well-established immunology portfolio in Europe and leverages our existing footprint, with five biosimilars now marketed in this therapeutic area,” the Company stated.

Rebecca Guntern, President Europe, Sandoz, said, “Timely and expanded access to safe, effective and affordable medicines can improve quality of life for millions of people living with chronic inflammatory diseases. Our goal is to make potentially life-changing medicines accessible to patients across Europe. Pyzchiva is one of the first ustekinumab biosimilars in Europe, which marks a significant milestone on that road.”

Pyzchiva is approved for 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.

Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people and significantly impacting patients’ quality of life. Plaque psoriasis is the most common form of psoriasis, affecting 85% to 90% of patients with psoriasis.

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 US, Canada, the European Economic Area, Switzerland, and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing, and supply.

Pyzchiva is a trademark of Samsung Bioepis Co. Ltd. Stelara is a trademark of Johnson & Johnson.

Pyzchiva (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara, a human monoclonal antibody against interleukin (IL)-12/23. 

Pyzchiva is available as a 130 mg concentrate in a vial for solution for infusion, additionally, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.