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Expert Analysis

Dance Marches On For Biosimilars In Amgen V. Sandoz

By Scott Pierce, Hamilton Brook Smith Reynolds PC ( January 13, 2017, 4:08 PM EST) -- Two sections of the Biologics Price Competition and Innovation Act of 2009 are the subject of writs of certiorari that have just been granted by the U.S. Supreme Court to the parties in Amgen Inc. v. Sandoz Inc. Ultimately at stake is billions of dollars in annual revenue generated in the burgeoning biologics industry. At issue is congressional intent settling patent disputes prior to expiry of a 12-year exclusivity period granted to the first licensee approved for commercialization of a biological product by the U.S. Food and Drug Administration....

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