Biosimilars and the BPCI Act Webinar

September 2, 2013 1:40 PM

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). 

This program will address patent and regulatory issues which arose from implementation of the BPCI Act since its implementation and the FDA’s three draft guidance’s.  The legal issues to be covered will include:

• 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• Regulatory pathway for biosimilars and FDA draft guidance on it, including study requirements and user fees;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.

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