BsUFA Reauthorization: A Primer
The Biologics Price Competition and Innovation Act of 2010 (BPCIA) created FDA’s biosimilar approval pathway. The first biosimilar was approved in 2015. As of January 2022, there are more than 30 FDA-approved biosimilars with dozens more in the queue. The Biosimilar User Fee Act (BsUFA) is a law authorizing FDA to assess and collect fees […]
AMGEN INC., AMGEN MANUFACTURING LIMITED v. SANDOZ INC.
The Biosimilars Council submitted an amicus brief urging the Supreme Court to permit biosimilar applicants to provide 180-day notice of commercial marketing prior to the FDA’s licensing of their application, instead of waiting until after FDA had licensed their product. On December 14, 2017, the Supreme Court agreed with the Council. This means that an […]
AAM Files Amicus Brief Supporting the BPCIA
WASHINGTON, DC (May 14, 2020) — The Association for Accessible Medicines (AAM) has filed an amicus brief in the latest constitutional challenge to the Affordable Care Act (ACA), arguing that even if the individual mandate of the ACA is deemed unconstitutional, the biosimilars pathway (BPCIA) should survive. “FDA-approved biosimilars offer patients and taxpayers enormous cost savings on life-saving treatments,” said AAM Interim CEO […]
AAM and the Biosimilars Council Applaud FDA’s Release of Enhanced Purple Book
WASHINGTON, DC (February 24, 2020) — “Today’s FDA action to enhance the Purple Book is a boon to those seeking to bring biosimilars to America’s patients. This update creates a single searchable electronic database that identifies each biosimilar and interchangeable biologic with its reference product, increasing transparency for patients, providers, payers, manufacturers and other stakeholders. […]
