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.