JERUSALEM--(BUSINESS WIRE)--Today, the Senate Health, Education, Labor and Pensions committee will take a significant step forward to ensure that the Food and Drug Administration (FDA) has the regulatory pathway necessary to establish an approval process for generic biologics. Teva applauds the Committee, especially Senators Kennedy, Enzi, Clinton and Hatch for their leadership, as well as Senator Schumer, in taking these important steps. The fundamental approach of the Biologics Price Competition and Innovation Act of 2007 is to address the scientific, regulatory and legal issues involved in bringing affordable biologics to the marketplace. The bill will create a scientifically-rigorous, efficient, FDA-driven pathway for both biosimilar and biogeneric products and include a mechanism intended for timely resolution of patent disputes.
