Uzpruvo by STADA & Alvotech Becomes Europe's First Approved Ustekinumab Biosimilar

STADA and Alvotech have introduced Uzpruvo® as the first biosimilar to Stelara® approved in Europe, now available in most major European markets. With pricing and reimbursement approvals in place, this launch follows the expiration of the European reference molecule patent, allowing immediate access to this crucial medicine for gastroenterology, dermatology, and rheumatology patients. Additional launches in other European countries are planned in the coming months, pending national price approvals, supported by a comprehensive European supply chain.

Peter Goldschmidt, CEO of STADA, said “Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets, promotes access by creating competition. This opportunity to improve patient access through wider usage of a life-changing biological treatment emphasizes STADA’s purpose of Caring for People’s Health as a Trusted Partner.”

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

In January 2024, the European Commission approved Uzpruvo as the first ustekinumab biosimilar, demonstrating equivalent efficacy, safety, pharmacokinetics, and immunogenicity to Stelara®. Uzpruvo is indicated for adults with Crohn's disease and psoriatic arthritis, as well as for adults and children aged 6 years and older with plaque psoriasis. However, it is not approved for ulcerative colitis, as Stelara® still holds exclusivity for this indication. Uzpruvo is available in a pre-filled syringe with a thinner needle compared to the reference product, and it is latex-free to reduce allergic reaction risks. Entirely developed, manufactured, and packaged in Europe, Uzpruvo boasts a 36-month shelf life.

STADA’s Global Specialty Head, Bryan Kim, also stated, “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. Physicians and patients can have full confidence that STADA has more than 15 years of experience in enhancing patient access through high-quality biosimilars in Europe, having launched our first biosimilar in 2008.”

Ustekinumab marks the second immunology biosimilar introduced through the collaboration between STADA and Alvotech, following the 2022 debut of Hukyndra, a high-concentration, citrate-free adalimumab therapy. Recently, the partners also announced their alliance in developing, manufacturing, and marketing AVT03, a proposed biosimilar to Prolia®/Xgeva® (denosumab). Alvotech handles the development and manufacturing of these biosimilars at its Reykjavik, Iceland facility, which operates on nearly 100% domestically produced renewable energy, including geothermal and hydroelectric power, reflecting both companies’ strong commitment to sustainability.

Uzpruvo is STADA’s seventh biosimilar available in Europe, with the German company also offering biosimilars in bone health, nephrology, oncology, and ophthalmology, in addition to specialized therapies in nephrology and neurology. Alvotech is a global leader in biosimilars, boasting a portfolio and pipeline of 11 biosimilars and candidates across various indications. Through its partnership network, Alvotech has launched a biosimilar to Stelara in Canada, Japan, and now Europe.