Alvotech and STADA Launch HUKYNDRA – Big Molecule Watch

Alvotech and Stada recently announced the launch of HUKYNDRA® to patients in certain European countries, including France, Germany, Finland, and Sweden.  HUKYNDRA® is a biosimilar of HUMIRA® (adalimumab) developed by Alvotech and is authorized for the treatment of a range of inflammatory conditions including psoriasis, Crohn’s disease, and ulcerative colitis.

STADA received approval from the European Commission to market HUKYNDRA® in European Union member countries, plus Norway, Iceland, and Liechtenstein in November 2021.  According to the press release, this is STADA’s fifth marketed biosimilar, and its first biosimilar to be commercialized by STADA in collaboration with Alvotech.  Alvotech stated that it plans to continue working in partnership with STADA to make European-made biosimilars available to European patients in the coming months and years, including the AVT04 ustekinumab biosimilar candidate to STELARA®, for which Alvotech recently announced clinical study results demonstrating therapeutic equivalence.