CHMP issues positive opinion for ustekinumab biosimilar
STADA and Alvotech have received a positive opinion from the European Medicines Agency's committee for Uzpruvo, the first ustekinumab biosimilar to Stelara proposed for authorization in Europe.
Frankfurt – STADA and Alvotech announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Uzpruvo (AVT04). This marks the first time the EMA has recommended authorization for a biosimilar to Stelara® (ustekinumab), a biologic therapy used for conditions including Crohn's disease, psoriasis, and psoriatic arthritis.
The positive opinion means Uzpruvo could be approved for marketing across all EU member states, as well as Iceland, Liechtenstein, and Norway. The introduction of an approved biosimilar is expected to significantly expand patient access by introducing competition into the European ustekinumab market, valued at approximately €2.5 billion.
Alvotech, responsible for the development and manufacturing of the biosimilar, partnered with STADA, which holds the commercial rights in Europe. STADA already markets six approved biosimilars and has established commercial operations in gastroenterology, dermatology, and rheumatology.
The marketing authorization application was supported by a comprehensive package of analytical, non-clinical, and clinical data. This included a pharmacokinetic similarity study in healthy subjects and a confirmatory clinical trial in patients with moderate to severe chronic plaque psoriasis, which demonstrated therapeutic equivalence between Uzpruvo and Stelara.
Upon regulatory approval, Uzpruvo is anticipated to offer a cost-effective treatment option, potentially lowering healthcare system costs and increasing patient access to ustekinumab therapies across Europe.