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Ustekinumab & Adalimumab – An Icelandic Innovation Saga?

Alvotech, headquartered in Reykjavik, Iceland, operates a vertically-integrated biosimilars platform from cell-line development through finished manufacturing, enabling control over cost and speed.

Its approved products include a high-concentration, low-volume adalimumab biosimilar (AVT02) and a ustekinumab biosimilar (AVT04) for immunology indications. The pipeline expands into treatments for autoimmune disorders, eye diseases, osteoporosis and oncology.

Recent milestones include: the U.S. launch of SELARSDI™ (ustekinumab-aekn), interchangeable with the reference biologic Stelara® for psoriasis, psoriatic arthritis and IBD. The U.S. FDA acceptance of the BLA for AVT06 (The FDA has accepted the Biologics License Application for AVT06, but approval is pending and expected in Q4 2025.), a biosimilar to aflibercept (Eylea®) for ophthalmology. 

A growing partnership network: for instance with Teva Pharmaceuticals in the U.S. and Advanz Pharma in Europe for multiple candidates. Strategic expansion includes the acquisition of Swedish R&D operations from Xbrane Biopharma AB and a biosimilar candidate to certolizumab pegol (Cimzia®). 

Financially, Alvotech reported 427% total revenue growth and 462% product revenue growth in 2024, driven by biosimilar launches and hope to be free cash-flow positive in 2025. Through its full stack model—R&D, manufacturing, global partnerships—Alvotech aims to lower biologic costs while scaling global access.

Key points:

  • Vertically-integrated biosimilars platform: cell-line to fill-finish.
  • Approved biosimilars: AVT02 (adalimumab), AVT04 (ustekinumab).
  • Pipeline targets: autoimmune, ophthalmology, osteoporosis, oncology.
  • U.S. launch: SELARSDI™ biosimilar to Stelara®.
  • U.S. regulatory filing: AVT06 biosimilar to Eylea®.
  • Global commercialization partners: Teva (U.S.), Advanz Pharma (Europe).
  • Acquisition of Swedish R&D operations from Xbrane, adding candidate for Cimzia®.
  • Financial momentum: >400 % revenue growth in 2024, aiming for free cash flow in 2025.
  • Manufacturing site in Iceland uses single-use technology, nearly 100 % renewable energy.
  • Strategic goal: expand access to high-quality biologics at lower cost globally.

Alvotech is a pure-play biosimilars company with a vertically integrated manufacturing platform, an expanding pipeline across immunology, ophthalmology and oncology, global commercialization partnerships, and strong financial momentum aimed at making biologics more affordable worldwide.

Ustekinumab is a biologic medication used to treat several autoimmune disorders.

Adalimumab is a TNF blocker that treats various autoimmune conditions, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

For company information: Alvotech – Better Access Better Lives

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