AbbVie, Alvotech Resolve US Patent Dispute Related To Humira Biosimilar


Alvotech Holdings S.A. has entered into a settlement agreement with AbbVie Inc ABBV, allowing Alvotech to market AVT02 (100 mg/mL), its high-concentration, citrate-free biosimilar adalimumab that references Humira, in the U.S.

  • The settlement fully resolves all pending U.S. disputes between the two companies related to the adalimumab biosimilar, including the International Trade Commission (ITC) case filed in December 2021. AbbVie alleged that Alvotech developed AVT02 through the theft of trade secrets. 
  • Also See: Biosimilar Player Alvotech To Go Public Via $2.5B Oaktree SPAC Merger.
  • Alvotech will be allowed to market AVT02 beginning July 1, 2023, making it the third adalimumab biosimilar to enter the U.S. market, following Amgen Inc’s AMGN Amjevita, which is expected to launch in January 2023, and Organon & Co OGN and Samsung Bioepis’ Hadlima, expected to launch in July 2023.
  • Viatris Inc VTRS and Fujifilm Kyowa Kirin’s Hulio and Coherus Biosciences Inc’s CHRS Yusimry are also anticipated to launch in July 2023.
  • Price Action: ABBV shares traded 1.23% higher at $148.96 in pre-market on the last check Wednesday.
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