Alvotech and Stada debut uzpruvo, the first ustekinumab biosimilar in Europe

A biosimilar to ustekinumab, Uzpruvo, has been launched this week by German pharma company Stada Arzneimittel and Iceland-based biosimilar company Alvotech to coincide with the expiry of exclusivity rights for the original therapy.

Developed by Janssen Pharmaceuticals (now owned by US big pharma Johnson & Johnson), ustekinumab is an injected monoclonal antibody therapy targeting interleukin (IL)-12 and IL-23 and is known by several brand names including Stelara.

It achieved its first US FDA and European approvals in 2009 for treatment of psoriasis and is now approved for treatment of other autoimmune conditions including Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

The first biosimilar of ustekinumab, Amgen’s Wezlana, was approved​ in the U.S. at the end of 2023, and Alvotech and Stada’s Uzpruvo was the first to be approved​ in Europe in January. As with other biosimilars, approval requires equivalent efficacy, safety, pharmacokinetics and immunogenicity to the reference product, in this case Stelara.

“We are delighted at the launch of Uzpruvo in Europe and to be first-to-market,” commented Robert Wessman, CEO of Alvotech, in a press statement. “This launch symbolizes the robustness of our platform, the value of our partnership with Stada, and our collective focus on the importance of biosimilars.”

Providing better access to effective therapies ​

While effective, until now ustekinumab has been an expensive medication with an average price for one low dose injection in the EU of around €4500, depending on the country, and as much as US $19,000 for one high-dose injection in the U.S.

Pricing for biosimilar versions of the monoclonal antibody will be considerably lower, making it more accessible for patients. For example, the price of a pre-filled syringe of Uzpruvo in the UK is set​ at just under £2000.

“Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets promotes access by creating competition,” stated Stada CEO Peter Goldschmidt.

“With comparable safety, efficacy and immunogenicity, Uzpruvo gives clinicians an opportunity for a seamless and simple switch for their patients, who can benefit from a thinner needle and latex-free syringe,” commented Stada’s Global Specialty Head, Bryan Kim.

Biosimilar experts​

This is the second biosimilar brought to the market by Stada and Alvotech. In 2022, they launched a biosimilar of another monoclonal antibody adalimumab (also known as Humira) for treatment of rheumatoid arthritis and other related autoimmune conditions.

The two companies also have more biosimilars in the pipeline, with Alvotech focusing on manufacturing at its production facility in Reykjavik, and Stada on commercialization and sales within the European region.

Stada already has six other biosimilars approved in the EU.