The Burrill Report (March 29, 2010): Healthcare Reform Opens the Door to Copycat Biologics (.MP3,7.84 Mb)
When President Obama signed healthcare reform legislation it contained a provision that opens the doorway to biosimilars—copycat versions of biologics that are no longer protected by patents. The legislation was viewed as a big victory for the biotech industry because it provides for a 12-year period of protection from biosimilar competition for these expensive therapies, but big questions remain as to how the U.S. Food and Drug Administration will construct a pathway for biosimilar approvals. We spoke to Erika Lietzan, a partner with Covington & Burling in the lawfirm’s food and drug group and government affairs group. She discussed the significance of the legislation, the challenges ahead for the FDA, and what points of controversy remain to be resolved.