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Sandoz unveils biosimilar Pyzchiva across Europe to treat chronic inflammatory diseases
Basel: Sandoz has announced the launch of Pyzchiva (ustekinumab) across Europe. Pyzchiva, developed and registered by Samsung Bioepis, a ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including the 130mg vial initiation dose for Crohn’s disease.
"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.
Read also: Sandoz confirms European Commission nod of Pyzchiva
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751