STADA and Alvotech launch Uzpruvo (ustekinumab biosimilar), the first approved ustekinumab biosimilar to Stelara, across Europe.
STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry
The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology. Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain.
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.
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