We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Supreme Court: 180-Day Biosimilar Exclusivity Can Start Any Time, Not Just After Approval
Supreme Court: 180-Day Biosimilar Exclusivity Can Start Any Time, Not Just After Approval
In a decision that reshapes the patent dance between biosimilar applicants and reference holders — and could affect the course of billions of dollars in the pharmaceutical industry — the U.S. Supreme Court ruled biosimilar manufacturers do not have to wait for FDA approval before beginning a six-month delay on commercial marketing.