Sean O'Connor, U.S. Perspective on IP and Antitrust Issues in Proposed Biosimilars Regulatory Pathway, in LES PRATIQUES DE L'INDUSTRIE PHARMACEUTIQUE AU REGARD DU DROIT DE LA CONCURRENCE 129-49 (Clotilde Jourdain-Fortier & Isabelle Moine-Dupuis eds., LexisNexis Litec 2010).
Prof. O'Connor's chapter focuses on the regulation of follow-on biologics, which are "intended to be sufficiently similar to a product already approved." He reviews provisions of the new Biologics Price Competition and Innovation Act of 2009 (enacted as part of the
Patient Protection and Affordable Care Act), the Drug Price Competition and Patent Term Restoration Act, and related laws and regulations. He also explores the patent system and reverse payment settlements.
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