Alvotech and STADA Pave Way partner together

Alvotech, an Iceland-based global biopharmaceutical company, has announced that all intellectual property disputes with AbbVie related to its AVT02 biosimilar candidate have been resolved.

“This resolution is an important step in Alvotech’s mission to bring more sustainable healthcare to patients in need. We look forward to launching our first biosimilar in the European market with STADA,” said Robert Wessman, Founder and Chairman of Alvotech.

According to Alvotech, this paves the way to commercializing AVT02 in European countries under the HUKYNDRA® brand name.

With all intellectual-property issues now resolved, STADA, (Alvotech’s exclusive strategic partner for commercializing AVT02) is preparing to launch the HUKYNDRA citrate-free, high-concentration biosimilar broadly across Europe. STADA is Alvotech’s exclusive strategic partner for commercializing AVT02 in Europe and selects other territories.

According to a statement from Alvotech, AVT02 is a monoclonal antibody and biosimilar to Humira® (adalimumab). It is approved in the EU, Canada, and the United Kingdom but under different names. AVT02 dossiers are under review in multiple countries; in the U.S., the BLA is in deferred status, pending FDA inspection(s).