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US Supreme Court to Consider Biosimilar Patent Process Next Week

(Regulatory Focus) Apr 20, 2017 - The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

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Dean Gesme, MD (Posted: April 21, 2017)

quotesThis will only determine how much delay is allowed by the courts and how excessive the legal expenses will be for every new biosimilar to enter the market. If the point is saving money while saving lives, how has our legal system gone so wrong?quotes

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