The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Waxman Drives Hard Bargain on FOBs Market Exclusivity

Representatives Waxman (D-CA), Pallone (D-NJ) and Deal (R-GA) released the Promoting Innovation and Access to Life Saving Medicine Act today, a.k.a. Follow-On Biologics legislation. The legislation provides a five-year initial exclusivity for products with a unique molecular structure. The Biotechnology Industry Organization is not too happy. In the past BIO has called for a 14-year data exclusivity

Perhaps actions South of the Border will move the ball forward at Health Canada on its regulatory pathway for biosimilars? It has been almost exactly a year since Health Canada’s draft guidance on biosimilars was published. Health Canada subsequently published a summary of its Consultation on the Regulatory Framework for Subsequent Entry Biologics following a stakeholder meeting in June.

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3 responses to “Waxman Drives Hard Bargain on FOBs Market Exclusivity

  1. Pingback: The Cross-Border Biotech Blog

  2. Pingback: Trends in 2009: Shifting IP Constituencies « The Cross-Border Biotech Blog

  3. Pingback: FTC Weighs in Favoring Compromise on Biosimilars Exclusivity, Disfavoring Pay-For-Delay « The Cross-Border Biotech Blog

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