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  • 10/11/2023
  • Press Release

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

  • CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within gastroenterology, dermatology and rheumatology

  • Positive CHMP opinion for Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including AVT04-GL-301 study for pharmacokinetic similarity in healthy subjects and confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis

  • The market entry of an approved biosimilar into the approximately €2.5 billion EU ustekinumab market could significantly expand patient access via competition


Bad Vilbel/Reykjavik – 10 November 2023 – Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab).

The positive CHMP opinion for Uzpruvo marks the first time that the EMA has proposed authorizing a biosimilar to the Stelara reference product. A marketing authorization with the indications Crohn’s disease, psoriasis and psoriatic arthritis would be valid across all European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway.

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.

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.

STADA’s Global Specialty Head, Bryan Kim, commented: “This positive CHMP opinion puts STADA and Alvotech in prime position to improve patient access in the ustekinumab and interleukin inhibitor markets. As a pioneer in driving biosimilar competition, STADA looks forward to offering Europe’s gastroenterologists, dermatologists and rheumatologists a valuable and cost-effective treatment option.”

Alvotech Chief Scientific Officer Joseph McClellan stated: “Having already partnered with STADA to bring a high-concentration adalimumab biosimilar to multiple European markets, Alvotech looks forward to increasing patient access to therapies for therapies for inflammatory conditions with our ustekinumab biosimilar.”

Ustekinumab is a human IgG1κ monoclonal antibody (mAb). AVT04 was designed using the Sp2/0 host cell line and is manufactured using a 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.

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 by value with annual sales in excess of €2.5 billion. 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 healthcare systems.