Alvotech and STADA pave way to launching Hukyndra, a Humira biosimilar

Iceland-based Alvotech Holdings today announced the resolution of all intellectual property disputes with AbbVie (NYSE: ABBV) in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate.

This paves the way for Alvotech’s exclusive strategic partner German drugmaker STADA Arzneimittel (SAZ: Xetra) to commercialize AVT02, a citrate-free, high-concentration (100 mg/mL) biosimilar to Humira (adalimumab) in European countries und er the Hukyndra brand name. In December last year, STADA received approval from The European Medicines Agency for the biosimilar.

Under the terms of the European patent resolution, AbbVie has granted Alvotech a non-exclusive, royalty bearing license to AbbVie’s intellectual property relating to Humira in Europe and in selected markets outside of Europe, thus paving the way for greater patient access to adalimumab.