Stada & Alvotech Secures European Marketing Approval For Uzpruvo

Stada and Alvotech announced that the European Commission has granted marketing permission for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab). The unified marketing authorization for Europe's first ustekinumab biosimilar is valid in all EEA countries, including the 27 EU Member States, 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, as per pharmabiz.

Stada’s global specialty head, Bryan Kim, commented: “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 commercial 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.”

The European Commission issued a marketing authorization after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in November 2023 to approve Uzpruvo for Crohn's disease, psoriasis, and psoriatic arthritis indications.

Alvotech is largely responsible for the development and production of the AVT04 ustekinumab biosimilar, as part of a strategic partnership established in 2019. Stada has commercial rights in Europe, where it already promotes six authorized biosimilars, including those for gastrointestinal, dermatological, and rheumatic indications. These include a high-concentration, citrate-free adalimumab biosimilar developed and sold in collaboration with Alvotech and Stada.