Archive: June 22, 2015

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The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”).  As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs.  However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”

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