McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “FDA releases further guidances for its biosimilar drug approval pathway” that appears in the March 2017 online edition of DDNEWS. The FDA recently released three new “Guidances for Industry” related to its implementation of the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). The first of these, released on December 29, 2016, and entitled Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, is directed to products for which “pharmacokinetic (PK) and pharmacodynamic (PD) data are needed to support a demonstration of biosimilarity” (presumably all biosimilar products). The rubrics set forth in this guidance are intended to be relevant for establishing that there are no “clinically meaningful differences” between the biosimilar and the reference biologic drug product. view the article
