Press Release

PhRMA Statement on the Proposed Biosimilar User Fee Act (III) Performance Goals Letter

WASHINGTON, D.C. (September 21, 2021) – Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement today on the release of the Biosimilar User Fee Act (III) Performance Goals Letter:

“The Biosimilar User Fee Act (BsUFA) is vital to the regulatory review of biosimilar and interchangeable biosimilar products and the mission of the U.S. Food and Drug Administration (FDA) to protect and advance public health. Since its enactment in 2012, BsUFA has played an essential role in strengthening the FDA’s ability to implement a regulatory review approach that supports timely development of biosimilar biological products and is consistent with the Agency’s high standards for scientific rigor and patient safety. While the U.S. has not had a biosimilar market in place as long as the European Union (EU), the U.S. market has significantly evolved over the last decade and is rapidly gaining ground. In fact, the U.S. has approved more biosimilar products than the EU had in a comparable period of time. This is largely due to the regulatory predictability and efficiencies that have been provided by the FDA’s successful implementation of the abbreviated approval pathway for biosimilars and the resources provided through BsUFA.

“Today’s release of the BsUFA III Performance Goals Letter is an important milestone in the ongoing evolution of the biosimilar marketplace in the U.S., increased options for patients and decreased prescription drug spending. Currently, there are 31 FDA-approved biosimilar products, including one interchangeable biosimilar and as a result of growing competition, annualized savings due to biosimilars reached $6.5 billion in 2020 and potential savings are estimated to exceed $100 billion over the next four years. Additionally, as of June 2021, there are nearly 100 active biosimilar development programs paying BsUFA fees and benefiting from BsUFA-funded meetings with FDA.

“BsUFA III initiatives will build on the success of the program and help increase timely access to safe and effective biosimilars for patients. PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and other stakeholders to ensure timely reauthorization of the BsUFA program as we continue working together to help patients live longer, healthier lives.”

Key provisions in the BsUFA III performance goals letter include:

  • Advancing development of interchangeable biosimilar products, including additional guidance to sponsors, and piloting a regulatory science program with demonstration projects focused on advancing the development of interchangeable biosimilar products and improving the efficiency of biosimilar product development.
  • Commitments to timelines for certain application supplements, including those seeking to update safety labeling to reflect changes to the reference product labeling, to provide enhanced consistency and predictability of review timelines.
  • Enhancing manufacturing inspection-related communications and modernizing facility assessment approaches.
  • Modernizing FDA’s information technology (IT) infrastructure and supporting adoption of cloud-based technologies.
  • Enabling timely interactions with the FDA for sponsors during biosimilar development and review, including establishment of a new meeting type for rapid, targeted feedback.
  • Enhancing FDA hiring, retention, and financial management.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $1 trillion in the search for new treatments and cures, including $91.1 billion in 2020 alone.

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