AbbVie's Fourth Humira Patent Settlement Allows Sandoz Biosimilar US Entry Eight Months After Amgen
Sandoz joins list of companies that opt to settle rather than challenge AbbVie's hefty patent portfolio; staggered launches offer model for future deals.
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AbbVie's Humira settlements suggest issues that FTC will be scrutinizing, such as biosimilar entry date, royalty payments, and acceleration clauses.
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.
Agreement with AbbVie allows Amgen to launch its Humira biosimilar in Europe in 2018 and in the US in 2023; it may be akin to generic settlements but it is uncertain if other sponsors will get similar deals.