After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.
By signing the FDA User Fee Reauthorization Act of 2022, President Biden also reauthorized the Biosimilar User Fee Act, also known as BsUFA III. The reauthorization will enable the FDA to assess and collect fees for biosimilars from October 2022 to September 2027.
“The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2023-2027…. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient,” the FDA commented on its website.
For several months, advocates and industry leaders have been calling on the administration to advance BsUFA III, including representatives from the Biosimilars Forum, the Biosimilars Council, and the Association for Accessible Medicines.
“We are committed to developing a robust biosimilar industry in the US, and to help the BsUFA program further develop over the next five years. We are at a critical inflection point for the biosimilars industry and we believe that enhancing the process for biosimilar development, review and educating the public of the importance of biosimilars is critically important to sustaining and cementing the biosimilar pathway for years to come,” said Juliana (Julie) M. Reed, executive director of the Biosimilars Forum in an April 2022 letter to the Senate Committee on Health, Education, Labor and Pensions encouraging the progression of BsUFA III.
The bill for BsUFA III was originally introduced to Congress in February 2022 by Representative Angie Craig (D-Minnesota). It passed in the House on March 31 and passed in the Senate on September 29 with an amendment.
When collecting user fees for biosimilars, the FDA applies them to “expediting the process for the review of biosimilar biological product applications, including postmarket safety activities.” According to the FDA, BsUFA assists biosimilar development and expedites the development process to get these products to the American public sooner.
The original BsUFA became law in 2012 and it was last reauthorized in 2017. Between March 2021 and June 2021, the FDA developed the changes for BsUFA III through collaboration with drug industry representatives. In November 2021, the FDA held a virtual BsUFA III Reauthorization Proposed Enhancements Public Meeting, during which members of the public were invited to hear opening remarks, background on BsUFA III, and overview of recommendations for reauthorization, industry perspectives, and public comment. A similar meeting also occurred in November 2020. The enhancements that FDA developed as a result of these meetings and consultations were referred to Congress in January 2022 as part of Title IV of the FDA User Fee Reauthorization Act.
The FDA released a commitment letter for BsUFA III that outlined the performance goals and procedures for the act for the next 5 years. The letter highlighted the FDA’s commitment to using BsUFA III to:
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
2 Commerce Drive
Cranbury, NJ 08512