Biosimilar Patent Settlements: What Terms May Spur Antitrust Actions?
Executive Summary
AbbVie's Humira settlements suggest issues that FTC will be scrutinizing, such as biosimilar entry date, royalty payments, and acceleration clauses.
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US Biosimilars: FDA Seeks To Build On Record Number Of Approvals, But Shutdown May Blunt Progress
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.