Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA’s Review of Biosimilar Applications Citing a Reference Product and BLA That Predates the BPCIA

January 24, 2014

New York, NY

Zuckerman Spaeder LLP partner Carlos Angulo participated in a point-counter-point debate on the potential use of trade secrets in connection with the Food and Drug Administration's (FDA) review of biosimilar applications. The debate focused on legal issues surrounding Abbott’s 2012 citizen petition to the FDA, which involved biologics license applications (BLA) submitted prior to passage of the Biosimilar Price Competition and Innovation Act (BPCIA). Mr. Angulo analyzed the legal arguments contained in the Abbott petition, including the potential classification of information contained in a BLA as a trade secret and the extent of the FDA’s biosimilar authority under the BPCIA.

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