STADA and Alvotech Launch Uzpruvo, Europe's First Stelara Biosimilar

STADA and Alvotech have announced the launch of Uzpruvo®, the first approved biosimilar to Stelara® available in Europe, following the expiry of exclusivity rights for the reference molecule. This launch spans several key European markets, backed by secured pricing and reimbursement approvals. The introduction of Uzpruvo aims to broaden patient access to critical treatments within gastroenterology, dermatology, and rheumatology at the earliest opportunity.

STADA’s Chief Executive Officer, Peter Goldschmidt, emphasized the importance of this launch in fostering competition and enhancing patient access to high-quality, life-changing biological treatments. Robert Wessman, CEO of Alvotech, highlighted the launch as a testament to the strength of their partnership with STADA and the value of their biosimilar platform.

In January 2024, Uzpruvo received approval from the European Commission, confirming its equivalent efficacy, safety, pharmacokinetics, and immunogenicity compared to the Stelara® reference product. Uzpruvo is indicated for the treatment of Crohn’s disease and psoriatic arthritis in adults, and plaque psoriasis in both adults and children from the age of six. However, it is not approved for the treatment of ulcerative colitis due to existing exclusivity rights for the originator product.

Uzpruvo is available in a pre-filled syringe with a thinner needle and is latex-free, reducing the risk of allergic reactions. This biosimilar is developed, manufactured, and packaged entirely within Europe and boasts a 36-month shelf life. Bryan Kim, STADA’s Global Specialty Head, noted that the medication’s safety, efficacy, and immunogenicity provide a seamless switch for clinicians and patients, offering additional benefits like a thinner needle.

This launch marks the second immunology biosimilar from the STADA and Alvotech partnership, following the 2022 introduction of Hukyndra, a high-concentration adalimumab brand. The two companies are also collaborating on a biosimilar for Prolia®/Xgeva® (denosumab), with Alvotech handling the development and manufacturing processes. Alvotech’s facility in Reykjavik, Iceland, uses nearly 100% renewable energy, aligning with the sustainability commitments of both companies.

Uzpruvo is the seventh biosimilar provided by STADA in Europe, extending their portfolio that includes treatments within bone health, nephrology, oncology, and ophthalmology. Alvotech, a global leader in the biosimilar sector, has a diverse pipeline of 11 biosimilars covering various medical conditions and has established a broad network of commercial partnerships to expand its reach globally.

STADA, headquartered in Bad Vilbel, Germany, is focused on consumer healthcare products, generics, and specialty pharma. It operates in approximately 115 countries, with significant financial achievements in recent years. Alvotech, founded by Robert Wessman, is a biotech company dedicated to developing biosimilar medicines with a broad pipeline aimed at treating various disorders and diseases. Through strategic partnerships, Alvotech has a wide-reaching presence in markets including the United States, Europe, Japan, China, and several other regions globally.