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Health Care Policy and Law
January 2018

The Supreme Court Ruling in Sandoz v Amgen: A Victory for Follow-on Biologics

Author Affiliations
  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • 2Solomon Center for Health Law and Policy, Yale Law School, New Haven, Connecticut
  • 3Harvard Health Publishing, Harvard Medical School, Boston, Massachusetts
  • 4Health Care Policy and Law Editor, JAMA Internal Medicine
JAMA Intern Med. 2018;178(1):5-6. doi:10.1001/jamainternmed.2017.6145

In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-cost versions of innovator biologics—ruling 9-0 in Sandoz v Amgen.1 The decision ruled that follow-on biologic companies are not required to share their licensing application with the innovator company and that a required 180-day notice to the innovator company before commercial marketing could be given before US Food and Drug Administration (FDA) approval of their product. This handed the nascent follow-on biologics industry a substantial, albeit incomplete victory, which may help reduce prices and improve patient access to biologic therapies.

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