Sandoz launches European ustekinumab biosimilar

Sandoz has announced the European launch of Pyzchiva, a biosimilar to Johnson and Johnson's Stelara, approved for various autoimmune conditions such as psoriasis and Crohn’s disease. This biosimilar was found to have equivalent efficacy and comparable safety to its reference treatments in a Phase III trial conducted in 2021. The European Medicines Agency (EMA) approved Pyzchiva in April, and following the US Food and Drug Administration (FDA) approval in June, Sandoz plans to introduce it to the US market in February 2025.

The European launch follows an agreement between Sandoz and Samsung Bioepis, finalized in September 2023. Under this agreement, Sandoz has commercial rights to Pyzchiva in the US, EU, UK, Switzerland, and Canada, while Samsung Bioepis retains intellectual property rights and is responsible for the drug's development and supply. Pyzchiva is now part of Sandoz’s portfolio, which includes five other biosimilars for autoimmune disorders.

Europe has the highest prevalence of psoriasis globally, with an estimated 6.4 million people affected, 85% of which are cases of plaque psoriasis. Western Europe, along with North America, also has the highest prevalence of Crohn’s disease, creating a significant demand for affordable therapeutic options.

Market data from GlobalData indicates that the market for psoriasis treatments has doubled since 2014, potentially reaching $13.1 billion globally and $4.13 billion in the EU by 2024. While Stelara earned $10.8 billion in 2023, its sales are projected to decline to $2.9 billion by 2028. Pyzchiva is expected to benefit from this growing market, with global sales projected to rise to $120 million in 2025 and $339 million by 2028.

Pyzchiva is not the only ustekinumab biosimilar approved in Europe, but it is the first available in 90mg or 45mg concentrations for injection and a 130mg concentration for infusion, matching the effective dose strengths of the reference medicine. Ustekinumab targets interleukins IL-12 and IL-23, which are crucial in the pathogenesis of several inflammatory diseases. By inhibiting these interleukins, it reduces inflammation and modulates the body’s immune response, providing therapeutic effects for conditions like psoriasis and Crohn’s disease.