The American Bar Association (ABA) Section of Science and Technology, Section of Intellectual Property Law, and Center for Professional Development are offering a live webinar entitled “Biosimilars and the BPCI Act: Where Are We Now and Where Are We Going?” on September 19, 2013 from 1:00 to 2:30 pm (US Eastern time).
• When to use biosimilar pathway in section 351(k) of the Public Health Service Act versus the biologics license application pathway in section 351(a);
• Regulatory pathway for biosimilars and FDA draft guidance on it, including study requirements and user fees;
• Interchangeability and state substitution laws;
• Evolving policy on naming of biosimilars;
• Issues in exclusivity for innovative biologics and implications for business strategies;
• The mechanics of the patent litigation process under the BPCIA; and
• Practical steps to prepare for the information exchange process.
Ken Burchfiel of Sughrue Mion, PLLC; John M. Engel of Engel & Novitt, LLP; William J. Simmons of Sughrue Mion, PLLC and Krista Hessler Carver of Covington & Burling LLP will be online and those interested in registering for the webinar, can click here for more information.