STADA and Alvotech secure approval for Europe’s first ustekinumab biosimilar to Stelara

The European Commission has issued a marketing authorization for STADA and Alvotech’s Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab).

The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein and Norway.

This European marketing authorization for Uzpruvo paves the way for market entry as soon as possible following the expiry in July 2024 of a European Supplementary Protection Certificate (SPC) for Stelara.

Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology and rheumatology.

STADA’s Global Specialty Head, Bryan Kim, said: “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 six marketed biosimilars, STADA looks forward to offering Europe’s gastroenterologists, dermatologists and rheumatologists a further cost-effective treatment option.”

Anil Okay, Chief Commerical Officer of Alvotech, said: “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.”

The European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) in November 2023 adopted a positive opinion on approving Uzpruvo with the indications Crohn’s disease, psoriasis and psoriatic arthritis.

Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar. STADA holds commercial rights within Europe, where the company already markets six approved biosimilars, including in gastrointestinal, dermatology and rheumatology indications. These include a high-concentration, citrate-free adalimumab biosimilar developed and marketed through the partnership between Alvotech and STADA.

In February 2023, the partners announced that that the EMA had accepted their marketing authorization application for AVT04, based on a comprehensive package of analytical and clinical data. This included data from the AVT04-GL-301 confirmatory clinical, safety and efficacy study that met its primary endpoint, with results demonstrating therapeutic equivalence between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Pharmacokinetic similarity was demonstrated in the AVT04-GL-101 study.

Ustekinumab is a human IgG1κ monoclonal antibody (mAb). Uzpruvo is produced in Sp2/0 cells and is manufactured using the perfusion process, like the reference product Stelara. Ustekinumab selectively targets the p40 protein, a component common to both IL-12 and IL-23 cytokines that play crucial roles in treating immune-mediated diseases like Crohn’s disease, psoriasis and psoriatic arthritis.

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