EMA Approves First Ustekinumab Biosimilar, Uzpruvo, for Inflammatory Conditions
Key Insights
The European Medicines Agency (EMA) has granted marketing authorization to Uzpruvo, the first biosimilar to Stelara (ustekinumab), potentially expanding patient access through competition.
Uzpruvo is indicated for Crohn's disease, psoriatic arthritis (search), and plaque psoriasis (search), offering a cost-effective treatment option for millions of patients with these conditions.
Developed by Alvotech and marketed by STADA Arzneimittel (search), Uzpruvo's approval is based on clinical data demonstrating therapeutic equivalence to Stelara in moderate to severe plaque-type psoriasis.
The European Medicines Agency (EMA) has approved Uzpruvo, the first biosimilar to Stelara (ustekinumab), marking a significant step toward increasing patient access to ustekinumab treatment for inflammatory conditions. Indicated for Crohn's disease, psoriatic arthritis (search), and plaque psoriasis (search), Uzpruvo offers a potentially more cost-effective alternative to the reference product.
Developed by Alvotech and to be marketed by STADA Arzneimittel (search), Uzpruvo's approval follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use in November 2023. The introduction of Uzpruvo is anticipated to greatly expand patient access to ustekinumab treatment, particularly given that the European market for ustekinumab is valued at approximately €2.5 billion (US$2.7 billion).
Clinical Equivalence and Market Impact
The approval of Uzpruvo is supported by analytical and clinical data, including findings from the AVT04-GL-301 confirmatory clinical study. This study demonstrated therapeutic equivalence between AVT04 (Uzpruvo) and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Furthermore, the AVT04-GL-101 study confirmed the similarity between the pharmacokinetic profiles of the two products.
Bryan Kim, global specialty head at STADA, stated that Uzpruvo offers Europe’s gastroenterologists, dermatologists, and rheumatologists a further cost-effective treatment option. STADA estimates that around 95,000 patients are already using ustekinumab in the top-4 EU markets plus the UK, highlighting the potential impact of biosimilar competition on improving patient access at the same, or even lower, costs to European health care systems.
Mechanism of Action
Uzpruvo, a human IgG1κ monoclonal antibody, is produced in Sp2/0 cells via a perfusion process, mirroring the manufacturing of Stelara. It selectively targets the p40 protein (search), which is common to both interleukin (IL)-12 and IL-23 (search) cytokines. These cytokines play a crucial role in immune-mediated conditions such as Crohn's disease, psoriasis, and psoriatic arthritis (search).
Future Outlook
With the European Supplementary Protection Certificate for Stelara expiring in July 2024, Uzpruvo is expected to become available to patients soon. Anil Okay, chief commercial officer of Alvotech, expressed enthusiasm for spearheading biosimilar competition in the ustekinumab market, aiming to increase patient access to biologic therapies for inflammatory conditions.