First Approved Stelara Biosimilar Launched in Europe by STADA and Alvotech

Editor's note: this story was originally published on BioPharmInternational.com.

STADA and Alvotech have launched Uzpruvo in Europe, marking the first approved biosimilar to Stelara (ustekinumab) in the European market, according to a July 22, 2024 company press release. Uzpruvo is now available across a majority of European countries, including the largest markets in the region where pricing and reimbursement approvals have been secured to ease the biosimilar’s market entry.

This launch follows close on the heels of the expiry of exclusivity rights related to the European reference molecule patent. The availability of a biosimilar ustekinumab offers expanded access to patients, physicians, and payers for a therapy to treat certain indications in the gastroenterology, dermatology, and rheumatology disease areas. The companies expect to conduct additional launches in other European countries over the coming months following national price approvals and utilizing a fully European supply chain, according to the press release.

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

The European Commission approved Uzpruvo in January 2024, making the product the first ustekinumab biosimilar to be approved in Europe with equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the reference biologic, Stelara (1). Uzpruvo is indicated for treating Crohn’s disease and psoriatic arthritis in adults and for treating plaque psoriasis in adults and children aged from six years. Uzpruvo is not currently approved to treat ulcerative colitis, however, because the originator biologic still holds exclusivity in this indication.

“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 Bryan Kim, STADA’s Global Specialty head, in the press release.

Uzpruvo is offered in a pre-filled syringe that has a thinner needle than the reference biologic. The biosimilar is also latex-free to minimize the risk of allergic reactions. According to the companies, Uzpruvo was developed and is manufactured and packaged wholly within Europe. It has a shelf life of 36 months.

Ustekinumab is the second immunology biosimilar to reach the market through the STADA and Alvotech partnership. In December 2022 the companies launched Hukyndra a high-concentration, citrate-free adalimumab therapy, a biosimilar to Humira, on the European market (2).

Meanwhile, in June 2024, the partners expanded their collaboration by entering into a development, manufacturing, and marketing alliance for a proposed biosimilar candidate to Prolia/Xgeva (denosumab), a human monoclonal Immunoglobulin G2 antibody for treating osteoporosis in women and bone loss in men (3,4). Under this agreement, Alvotech is responsible for the development and manufacturing of biosimilars within the partnership at its Reykjavik, Iceland, facility.

References

1. European Commission. Union Register of Medicinal Products for Human Use. ec.europa.eu (accessed July 29, 2024).
2. Alvotech. Alvotech and STADA Broaden Access to Hukyndra Adalimumab Biosimilar in Europe. Press Release, Dec. 7, 2022.
3. Alvotech. Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership. Press Release, June 11, 2024.
4. EMA. Prolia. www.ema.europa.eu (accessed July 29, 2024).

Source: Alvotech