Humira's 'Unique' Number Of Patents Makes Biosimilar Entry Risky, Pfizer Says
Pfizer wants to get its adalimumab biosimilar to market as soon as possible, but won’t say whether that’s before AbbVie's patents run out in 2023.
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Several US senators have lent their backing to the draft Biologic Patent Transparency Act, as part of efforts to address “patent thickets” around brand biologics.
If approved in the US, Samsung Bioepis' adalimumab biosimilar may launch June 30, 2023, five months after the market entry date for Amjevita under Amgen's agreement with AbbVie; the 150-day marketing advantage for the first biosimilar approved suggests a benchmark for future patent litigation settlements.
AbbVie, for the second time, has resolved a Humira patent dispute that protects the drug's US commercial exclusivity until 2023. The latest deal with Samsung Biopesis follows a similar agreement with Amgen, giving Amgen a five-month head start with its biosimilar.