Status of U.S. Biosimilar Approvals and Pending Applications*

By Kevin E. Noonan — The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (colloquially called "Obamacare," Public Law 111-148) (see "House Passes Health Care Reform Bill — Biosimilar Regulatory Pathway Makes Cut, Pay-for-Delay Ban Does Not"). It gave the U.S. for the first time a pathway for FDA approval of alternatives to biologic drugs (termed "biosimilars" because the complexity of these molecules precludes the atom-for-atom identity of small molecule generic drugs), codified at 42 U.S.C. § 351(k), as well as provisions for resolving patent disputes between innovator biologic drug companies (termed…

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