is being presented by Patricia Carson, Partner, Kaye Scholer LLP and airs on Thursday, April 28th, 2011. For more details or to register, please visit our site at www.fxconferences.com
It has been only a little over a year since Congress passed into law a structured pathway for abbreviated approval of “follow-on biologics”. The follow-on biologics law, which was included as a subtitle of the Patient Protection and Affordable Care Act signed into law on March 23, 2010, is conceptually similar to what is commonly known as the Hatch Waxman Act. Just as Hatch Waxman created an abbreviated pathway for the approval of generic small molecule drugs, the follow-on biologics law creates an abbreviated pathway for generic biologics.
While conceptually similar to Hatch Waxman, the follow-on biologics law differs in a number of respects, reflecting the very different nature of biologics versus small molecules.
This audio conference presentation explores the mechanics of the follow-on legislation and how the branded industry should be preparing for the generic challenges to their branded biologics.
