15 February 2012
On February 9, 2012, the U.S. Food and Drug Administration (FDA) released draft guidelines regarding biosimilar product development. These draft guidelines supplement the abbreviated procedures for gaining FDA approval of biological products under § 351(k) . The abbreviated procedures require a showing of high similarity or interchangeability with an FDA-licensed biological product (reference product). These biological products are derived generally from human and/or animal materials including, among others, vaccines, proteins, tissues, blood and components thereof. While these guidelines may help a Sponsor position their biological product for approval, the Sponsor is still subject to litigation regarding relevant patents if procedures are not followed and precautions are not taken. Indeed, the Congressional Research Service recently published a white paper “Follow-On Biologics: The Law and Intellectual Property Issues” on January 24, 2012 .