AAM and Biosimilars Council comment on GDUFA and BsUFA negotiations

The US Association for Accessible Medicines (AAM) and the Biosimilars Council released the following statement from president and chief executive John Murphy III on recent Generic Drug User Fee Amendments (GDUFA) and upcoming Biosimilar User Fee Amendment (BsUFA) public meetings, negotiations, and congressional reauthorization:

“With the GDUFA IV public meeting now behind us and as stakeholders prepare for the upcoming BsUFA IV public meeting, we have an important opportunity to recognize the progress made through both user fee programs and what these agreements can mean for patients.