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

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.

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.

NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…

WASHINGTON (Reuters)—U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers. The nine justices heard arguments in an appeal by Novartis AG of a lower court…

As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…

As America’s capital, Washington, D.C., maintains an outsized influence in our daily lives. Despite having a meager sliver of the New York City population, the daily political transactions that transpire in the District of Columbia impact our lives. The comings and goings in the corridors of Congress are likely to have a greater impact on us…

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