The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by the House last month, as reported here. The President immediately signed it into law.
As we previously reported, the Biosimilar User Fee Act “BsUFA II” portion of the FDA
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee programs, including reauthorization of the Biosimilar User Fee Act (“BsUFA II”), was passed in the House of Representatives on July 12, 2017, with bipartisan support by voice vote. The House bill comes as
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end of September 2017. Under BsUFA, the U.S. Food and Drug Administration (“FDA”) is authorized to collect fees directly from biosimilar drug product applicants, and the fees are dedicated to expediting the approval
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars. During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.
According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled