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Web Date: July 8, 2016

U.S. appeals court maintains six-month notice for generic-like biological drugs

Ruling could delay introduction of lower-priced biosimilar
Department: Government & Policy
Keywords: biosimilars, biologic drugs, intellectual property

U.S. makers of generic-like versions of biological drugs must always give six months’ notice to brand-name rivals before launching their products, a federal appeals court ruled on July 5.

The decision by the U.S. Court of Appeals for the Federal Circuit has significant implications for when biosimilar drugs may enter the marketplace. It could slow competition that would likely lower the price of expensive brand-name biologic drugs.

The appeals court . . .

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Chemical & Engineering News
ISSN 0009-2347
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