The New 180 Days? Humira Biosimilar Deals Give Amgen 150-Day Jump On Samsung
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.
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Amgen’s manufacture in California of its biosimilar for the European market infringes three recently issued patents, says Coherus, which is considerably behind Amgen in developing its own copy of AbbVie’s Humira. Lawsuit highlights the key role that intellectual property is likely to play in protecting biosimilar formulations, one patent attorney says.
Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
Genentech inks second settlement of trastuzumab biosimilar litigation; suits ongoing against Amgen, Celltrion/Teva, and Samsung with joint claim construction proceedings.