EMA Recommends Approval for Uzpruvo Biosimilar

The CHMP's positive opinion for Uzpruvo is a historic moment as it is the first time the EMA has recommended a biosimilar to the Stelara reference product for authorization.STADA has commercial rights in Europe, and currently sells six approved biosimilars in areas such as gastrointestinal, dermatology, and rheumatology.The AVT04-GL-301 confirmatory clinical, safety and efficacy study included data that successfully met its primary endpoint. The results showed that AVT04 is therapeutically equivalent to Stelara in patients suffering from moderate to severe chronic plaque-type psoriasis.Bryan Kim, STADA's global specialty head, stated that the positive CHMP opinion has positioned STADA and Alvotech to enhance patient access in the ustekinumab and interleukin inhibitor markets. "STADA is excited to lead the way in biosimilar competition and is eager to provide Europe's gastroenterologists, dermatologists, and rheumatologists with an affordable and valuable treatment option."Joseph McClellan, the chief scientific officer of Alvotech, announced that Alvotech is excited to expand patient access to treatments for inflammatory conditions with their ustekinumab biosimilar, following their successful partnership with STADA to bring a high-concentration adalimumab biosimilar to multiple European markets.Ustekinumab is a monoclonal antibody (mAb) of the human IgG1 class. Ustekinumab is designed to specifically target the p40 protein, which is found in both IL-12 and IL-23 cytokines. These cytokines are highly involved in the treatment of immune-mediated conditions such as Crohn’s disease, psoriasis, and psoriatic arthritis.Stelara is among Europe's top-10 medicine brands in terms of value, with annual sales exceeding €2.5 billion. Approximately 95,000 patients are currently using ustekinumab in the top-4 EU markets and the UK. When Stelara's EU exclusivity rights expire, competition from biosimilars presents a big opportunity to enhance patient access while keeping healthcare costs the same or even lower for European healthcare systems.