EMA Approves First Ustekinumab Biosimilar, Uzpruvo

The European Medicines Agency (EMA) granted marketing authorization to Uzpurvo, the first biosimilar to reference Stelara (ustekinumab). The biosimilar is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis.

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The product was developed by Alvotech and will be marketed by STADA Arzneimittel as part of a 2019 exclusive commercialization agreement. Uzpruvo is expected to be available to patients following the July 2024 expiry of a European Supplementary Protection Certificate for Stelara.

“This first marketing authorization for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition. By adding to our current roster of 6 marketed biosimilars, STADA looks forward to offering Europe’s gastroenterologists, dermatologists, and rheumatologists a further cost-effective treatment option,” commented Bryan Kim, global specialty head at STADA, in a company statement.

According to STADA, the European market for ustekinumab is worth about €2.5 billion (US$2.7 billion) and the introduction of Uzpurvo and products like it will greatly expand patient access to ustekinumab treatment for millions of patients with gastrointestinal, dermatologic, and rheumatic conditions.

“With around 95,000 patients already using ustekinumab in the top-4 EU markets plus the UK, Stelara ranks among Europe’s top-10 medicine brands…. Biosimilar competition upon expiry of EU exclusivity rights for Stelara offers a significant opportunity to improve patient access at the same, or even lower, costs to European health care systems,” wrote the company.

The authorization came after the EMA’s Committee for Medicinal Products for Human Use took on a positive opinion on approving Uzpurvo in November 2023. The partners announced that the EMA accepted their marketing authorization application for Uzpurvo, at the time called AVT04. The applications included analytical and clinical data, including data from the AVT04-GL-301 confirmatory clinical, safety, and efficacy study demonstrating therapeutic equivalence between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Similarity between the products’ pharmacokinetic profiles was evaluated in the AVT04-GL-101 study.

Uzpruvo, a human IgG1κ monoclonal antibody, is generated in Sp2/0 cells through the perfusion process, mirroring the manufacturing approach of the reference product. Specifically designed, Uzpruvo selectively focuses on the p40 protein, present in both interleukin (IL)-12 and IL-23 cytokines, pivotal in addressing immune-mediated conditions such as Crohn disease, psoriasis, and psoriatic arthritis.

Anil Okay, chief commerical officer of Alvotech, remarked, “We look forward to spearheading biosimilars competition in the ustekinumab market and increasing patient access to biologic therapies for inflammatory conditions as we have done with our adalimumab biosimilar, launched last year.”