Sandoz Launches Pyzchiva® Autoinjector in Europe for Ustekinumab Biosimilar Treatment
Thursday, May 22, 2025
Sandoz has announced the launch of its Pyzchiva® autoinjector in Europe, marking the first commercially available autoinjector in the region for a ustekinumab biosimilar.
Pyzchiva® is a biosimilar of ustekinumab, with similar efficacy and safety compared to the reference medicine Stelara®. It targets interleukin-12 and interleukin-23 and is indicated for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and paediatric plaque psoriasis in eligible patients.
The autoinjector is based on the Molly® platform from SHL Medical AG and is available in two strengths: 90 mg in 1 mL and 45 mg in 0.5 mL. Pyzchiva® is also offered in pre-filled syringes and as a concentrate in vials for infusion.
Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of several chronic inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and paediatric plaque psoriasis in patients aged six years and older who weigh over 60 kg.
The newly introduced autoinjector is designed to support easier self-administration, offering features such as automatic dosing, reduced injection discomfort, compact design, and flexible storage. These benefits aim to improve patient experience and encourage better adherence to prescribed treatment plans.
Psoriasis affects an estimated 6.4 million people in Europe, making the region the most impacted globally. Inflammatory bowel diseases like Crohn’s disease are also widespread, with around 2.5 to 3 million people affected. Non-adherence to treatment can lead to worsening symptoms, more frequent disease flares, and increased healthcare costs due to hospitalisations and additional interventions.
Pyzchiva® plays a central role in Sandoz’s biosimilar strategy and is now available in 23 European markets, beginning with Spain and expanding further across the region. The product contributes to the company’s goal of improving access to treatment for patients with chronic inflammatory diseases.
Under a development and commercialisation agreement signed in 2023, Sandoz has exclusive rights to market Pyzchiva® in Europe, the UK, the US, Switzerland, and Brazil. Samsung Bioepis retains responsibility for development, registration, manufacturing, intellectual property, and supply.
Source: sandoz.com
