Morgan Lewis

Healthcare Reform—New Path for Biosimilars, presented at a Washington Legal Foundation Webcast

Published on: 05/20/2010

The new federal health law granted FDA broad discretion to create a formal approval process for "generic" versions of biotech drugs. This Washington Legal Foundation program discussed an approval pathway for biosimilars and what's next for FDA on healthcare law implementation.

As a part of the discussion, panelists:

  • Explained the federal law's provisions relating to biosimilars and FDA's mandate to implement them.
  • Assessed past requests that FDA approve generic versions of biotech drugs and how agency's actions might inform its creation of a new process.
  • Analyzed how FDA will balance the need for patient safety with the imperatives of timely consumer access to biosimilars.

View a recording of the webcast.

View Kathy's presentation slides on the left.

downloads/links:

pdfView Presentation http://www.morganlewis.com//pubs/Sanzo_BiosimilarsNewPath_20may10.pdf