We're Not in Kansas Anymore, Toto: Product Liability Biologics and Biosimilars

Biologic therapeutic products are a current focus of industry and government action.  Biologics are used to treat a wide variety of diseases, including cancer and immune disorders, and represent a large and fast-growing segment of health care therapies. On March 23, 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) that established an abbreviated pathway for FDA approval of "biosimilar" products, often thought of as the "generic" form of biologic products.  In a cutting-edge article published in For the Defense, Bridget Ahmann, Jennifer Dukart, Denise Kettelberger, and Joe Price forecast the potential product liability implications of the BPCIA and its proposed regulations. Their analysis will serve as a guide to biologics companies resisting attempts by plaintiffs to litigate in this novel arena.