Alvotech announces European launch of first-in-market biosimilar to Simponi® (golimumab) globally by partner Advanz Pharma

• Introduction of AVT05 supported by NHS England tender award in the United Kingdom
  
  

REYKJAVIK, Iceland, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that launches are underway in Europe for Gobivaz® (golimumab), Alvotech’s biosimilar to Simponi® (golimumab), also known as AVT05 (prefilled syringe and autoinjector). Gobivaz is the first marketed biosimilar to Simponi worldwide. It is being commercialized exclusively in Europe by Alvotech’s partner, Advanz Pharma Holdco Limited (“Advanz Pharma”).

In the United Kingdom, the introduction of Gobivaz is supported by a National Health Service (NHS) England tender award. This procurement decision provides a defined framework for adoption within NHS services and reflects the system’s focus on improving access to high quality biologic treatment options for immune mediated inflammatory diseases.

Availability across EEA markets will progress in line with national pricing and reimbursement processes.

“We welcome the introduction of Gobivaz into clinical practice across Europe following its approval as the first biosimilar to Simponi worldwide,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech. “Our biosimilar represents an important treatment option for patients, and the NHS England tender supports our aim of expanding the availability of high-quality biologic medicines.”

Approval of Gobivaz was supported by comprehensive analytical, pre-clinical and clinical studies that demonstrated biosimilarity to the reference product. Gobivaz is available in the same presentations and dosage forms as Simponi and is manufactured at Alvotech’s facility in Iceland.

For further information, please contact:

Media

Benedikt Stefansson, VP Investor Relations and Global Communications

Sarah Macleod, Head of Global Communications

Investor Relations

Balaji Prasad, Chief Strategy Officer

Patrik Ling, VP Investor Relations Scandinavia (SE)

Benedikt Stefansson, VP Investor Relations and Global Communications (IS)

About Alvotech

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit . None of the information on the Alvotech website shall be deemed part of this press release.

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