On January 19th, ASBM submitted comments to the FDA supportive of reauthorizing the Biosimilars User Fee Act (BsUFA) which funds the FDA’s biosimilar program through fees paid by biosimilar sponsors:
“ASBM supports reauthorization of BsUFA because the FDA must always have adequate funding and resources to bring these medicines to patients both safely and in a timely manner. Continuing the BsUFA funding mechanism…will ensure FDA has the resources it needs.”
The FDA had held a hearing on BsUFA December 18th, at which ASBM Steering Committee Member Andy Spiegel, Director of the Global Colon Cancer Association, testified in support of the program.
The comment letter ASBM submitted may be read in full here.