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U.S. Supreme Court Speeds Copycat Biologic Drugs to Market

Andrew Chung  |  

Amgen sued Sandoz in 2014 in San Francisco federal court alleging patent infringement and violations of the Affordable Care Act provision governing biosimilars.

The companies disagreed on how to apply that law’s requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version.

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In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval. Novartis appealed to the Supreme Court, with the Trump administration backing the company’s arguments.

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