US FDA’s Gottlieb Shuts The Door On Exclusivity For ‘Transition’ Biologics
US FDA’s Gottlieb Shuts The Door On Exclusivity For ‘Transition’ Biologics
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Commissioner Scott Gottlieb announced that exclusivity for certain existing protein products will not be extended further, in remarks made at the FDA/CMS Summit. The announcement affects existing products, including insulin and human growth hormone, that, under the Public Health Service Act, are “deemed to be licensed” in 2020.
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In a move likely to trigger lawsuits from innovator drug companies against the US FDA, agency commissioner Scott Gottlieb recently announced that existing insulins and other protein products would not obtain additional exclusivity upon attaining “deemed to be licensed” status under the Public Health Service Act. The news was part of a series of guidance documents issued by the agency in regard to the Biologics Price Competition and Innovation Act, which sees the reclassification of particular protein products from drugs to biological products effective March, 2020.
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