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Case Detail


In re FDA Approval of Biosimilars
(Regulatory Proceeding)
On February 13, 2013, WLF filed formal comments with the Food and Drug Administration (FDA), in support of Abbott Laboratory’s Citizen Petition that seeks to prevent FDA use of trade secret data to approve “biosimilar” competitors to Abbott’s biological products. WLF urged deferral of all work on any applications for approval of biosimilar products, where the application is based on a reference product for which the biologics license application (BLA) was filed before March 23, 2010 (the date that Congress adopted legislation permitting approval of biosimilars). WLF argued that approval of such biosimilar applications would require use of trade secret information that was submitted to FDA based on assurances that the trade secrets would remain inviolate. WLF asserted that use of such information to approve biosimilars would expose the federal government to massive liability under the Fifth Amendment’s Takings Clause.
Case Status:
Awaiting FDA action.
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