STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Ustekinumab (Stelara) in across a majority of European countries.
Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain.
“Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets, promotes access by creating competition,” says STADA CEO Peter Goldschmidt in a news release. “This opportunity to improve patient access through wider usage of a life-changing biological treatment emphasizes STADA’s purpose of Caring for People’s Health as a Trusted Partner.”
“We are delighted at the launch of Uzpruvo in Europe and to be first-to-market,” adds Robert Wessman, Chief Executive Officer of Alvotech. “This launch symbolizes the robustness of our platform, the value of our partnership with STADA, and our collective focus on the importance of biosimilars.”
In January 2024, Uzpruvo became the first ustekinumab biosimilar to be approved by the European Commission as having equivalent efficacy, safety, pharmacokinetics and immunogenicity to the Stelara reference product. Uzpruvo is indicated for Crohn’s disease and psoriatic arthritis in adults, as well as plaque psoriasis in adults and children aged from 6 years. Uzpruvo is currently not approved for the ulcerative colitis indication, since the originator still has exclusivity for this indication.
Uzpruvo is offered in a pre-filled syringe format featuring a thinner needle than the reference product and is latex-free to minimize the risk of allergic reactions. Uzpruvo was developed, and is manufactured and packaged, entirely within Europe, and has a 36-month shelf life.
Ustekinumab is the second immunology biosimilar brought to market through the strategic partnership between STADA and Alvotech, following the 2022 launch of the Hukyndra high-concentration, citrate-free adalimumab therapy.
