• Congress Establishes a New Regulatory Framework for the Approval of Biosimilars
  • April 20, 2010
  • Law Firm: Winston & Strawn LLP - Office
  • The Patient Protection and Affordable Care Act (“PPACA”) was enacted on March 23, 2010. In addition to including sweeping reforms regarding access to health care in the United States, the act also includes long-awaited provisions that lay out for the first time the general pathway in which generic biological products can be approved by the Food and Drug Administration (“FDA”). This briefing is a review of the key provisions of the new regulatory framework.