Lek, as part of Sandoz, the global leader in generic and biosimilar medicines, launches a new ustekinumab biosimilar intended to treat patients with chronic inflammatory diseases in Slovenia. The medicine is available on the market with all reference medicine strengths.
The launch strengthens the well-established immunology portfolio in Slovenia and marks the ninth biosimilar medicine from Lek. The new medicine is a key biosimilar driver, adding value and contributing to the company’s mid-term growth strategy.
It also strengthens the company’s goal of pioneering access for all patients and contributing to the sustainability of the health care system.
“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, including Slovenia. The new medicine is one of the first ustekinumab biosimilars in Slovenia and Europe, which marks a significant milestone on that road.”
Rebecca Guntern, President Europe, Sandoz
Sandoz’s ustekinumab biosimilar 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 the ustekinumab biosimilar with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize the medicine in the US, Canada, the European Economic Area, Switzerland, and the UK. Samsung Bioepis remains responsible for the development, registration, intellectual property, manufacturing, and supply.
About the Sandoz ustekinumab biosimilar
The ustekinumab biosimilar has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine from Johnson & Johnson, a human monoclonal antibody against interleukin (IL)-12/23. It has been approved for the 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.
The ustekinumab biosimilar is available with all reference medicine strengths.