• FDA’s Draft Biosimilars Guidance Documents: Overview and Implications
  • February 23, 2012 | Author: Daniel A. Kracov
  • Law Firm: Arnold & Porter LLP - Washington Office
  • On February 9, 2012, the US Food and Drug Administration (“FDA” or “the Agency”) released for comment its initial draft guidance implementing the Biologics Price Competition and Innovation Act (BPCIA), signed into law as part of the Affordable Care Act, which creates an approval pathway under section 351(k) of the Public Health Service Act (PHS Act) for biological products demonstrated to be “biosimilar” to or “interchangeable” with a licensed “reference” biologic product. In late 2010, FDA held a two-day public meeting and established a public docket to obtain input on implementation of the BCPIA, and stakeholders have been eagerly awaiting the draft guidance documents, which FDA had indicated would be released last year. Comments on the draft guidance documents should be submitted by April 16, 2012 to ensure consideration in the development of the final guidance. In addition, the Agency reportedly plans to convene another public meeting to obtain input on the draft guidance documents prior to the release of final guidance. www.arnoldporter.com