Sughrue Leads Debate on Issues in New US Biosimilar Pathway

Sughrue Mion, PLLC is moderating a cutting edge panel discussion on the state of biosimilars regulation at the American Bar Association’s Spring meeting on April 8, 2010, at the Marriott Crystal Gateway, Arlington, VA. Panel members include representatives from BIO, the FDA, the EMEA (European FDA), Sandoz and Eli Lilly and includes invited statements from Representative Waxman, Senators Hagan, Eschoo and Milkulski. Biosimilars are of tremendous interest globally, particularly in the US, one of the largest biologic markets in the world. Even though opportunities abound, biosimilar producers and patients face potential risks, requiring producers to develop innovative intellectual property strategies, carefully assess their research and development processes and production processes in order to guarantee the safety and efficacy of follow-on biologics. This discussion will explore the new US Biosimilar Approval Pathway and will include discussions of the barriers to entry in the US and abroad. For more information please see: