Sandoz has announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn’s disease.
Pyzchiva is a biosimilar of Johnson and Johnson Innovation Medicine’s (J&J) Stelara, which is approved for treating plaque psoriasis, psoriasis arthritis, and paediatric plaque psoriasis for patients six years and older and weighing over 60kg, as well as Crohn’s disease. In 2021, a Phase III trial (2020-006115-19) demonstrated equivalent efficacy and comparable safety between the biosimilar and reference treatments.
The launch comes after the European Medicines Agency (EMA) approved the therapy in April. Following a US Food and Drug Administration (FDA) approval in June, Sandoz has stated that it intends to launch the biosimilar for the US market in February 2025.
The launch came in the wake of an agreement between the Swiss company and Samsung Bioepis, finalised in September 2023. Sandoz holds the commercial rights to Pyzchiva in the US, the EU, the UK, Switzerland, and Canada. Meanwhile Samsung Bioepis retains intellectual property rights and remains responsible for development and supply of the drug. The biosimilar joins the Sandoz’s portfolio of five other biosimilars for autoimmune disorders on the market.
Launching Pyzchiva in Europe holds particular significance. The continent has the highest prevalence of psoriasis worldwide, estimated to affect 6.4 million people, with over 85% of cases presenting as plaque psoriasis. Along with North America, Western Europe is also home to the world’s highest prevalence of Crohn’s disease, creating ample demand for cheaper, more abundantly available therapeutic options.
According to GlobalData, the market surrounding psoriasis treatments is estimated to have doubled since 2014, potentially reaching $13.1bn globally and $4.13bn in the EU in 2024. While Stelara earned $10.8bn in 2023, the drug sales are estimated to drop to $2.9bn in 2028, as per GlobalData. Pyzchiva is set to benefit from this growing market, with its global sales projected to rise to $120m in 2025 and then further to $339m by 2028.
GlobalData is the parent company of Pharmaceutical Technology.
While not the sole ustekinumab biosimilar approved in Europe, Pyzchiva is the first that is available in 90mg or 45mg concentrations for injection and as a 130mg concentration for infusion—the same dose strengths shown to be effective for the reference medicine.
Ustekinumab targets IL-12 and IL-23, both interleukins, which are key to the pathogenesis of several inflammatory diseases. This inhibits signalling and further cytokine production, reducing inflammation and modulating the body’s immune response.
