Alvotech Resolved European Patent Dispute with AbbVie for AVT02 (biosimilar, adalimumab)
- Alvotech has resolved the disputes with AbbVie in the EU & selected markets outside of the EU related to AVT02 biosimilar. & has received a non-exclusive, royalty-bearing license to AbbVie’s IP relating to Humira
- Alvotech’s exclusive partner STADA will commercialize AVT02, a citrate-free, high-concentration (100 mg/mL) biosimilar to Humira in EU countries under the brand name Hukyndra & plans to launch it in the EU for inflammatory conditions inc. RA, PsO & CD
- The US FDA has accepted the BLA’s review for ATV02 in Feb 2022 based on a switching study that demonstrated bioequivalence, comparable efficacy, safety & immunogenicity switches of Humira vs AVT02
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