PhRMA Urged Reauthorization of Biosimilar Program

The trade association issued a statement advocating for the continued renewal of the Biosimilar User Fee Act.

Updated on Sept. 24, 2026 in Healthcare

PhRMA Urged Reauthorization of Biosimilar Program

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PhRMA has called on Congress to reauthorize the Biosimilar User Fee Act to ensure the ongoing stability of the FDA review process for biosimilar medicines. This move seeks to maintain the program that has facilitated regulatory oversight since its inception.

Why it matters

The program is designed to foster a competitive medicine marketplace by streamlining review processes. Strengthening this framework aims to expand available treatment options and reduce long-term health care costs for patients.

The Biosimilar User Fee Act program has supported the FDA review process since its establishment in 2012. The current proposal, BsUFA IV, aims to enhance review efficiency and resource utilization while increasing transparency between regulators and sponsors.

The players

PhRMA

The Pharmaceutical Research and Manufacturers of America is a trade group representing companies in the pharmaceutical and biotechnology industries.

FDA

The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of medical products.

Congress

The legislative branch of the United States federal government is responsible for drafting and enacting national laws including reauthorization acts.

The details

The BsUFA IV agreement focuses on refining communication channels and operational efficiency to accelerate the development of biosimilars. PhRMA maintains that these procedural improvements are essential for ensuring that patients receive timely access to affordable medications.

The Biosimilar User Fee Act program was established in 2012.
PhRMA issued a statement on the BsUFA IV Letter on September 24, 2026.

Market Landscape

This push for reauthorization aligns with the industry's broader reliance on the Biosimilar User Fee Act to maintain a stable regulatory environment. The sector views these user fee agreements as critical benchmarks for balancing timely drug approvals with necessary safety standards.

Average consumers may see an increase in the availability of lower-cost biosimilar treatment options if the reauthorization successfully streamlines the regulatory pipeline. These developments are intended to lower out-of-pocket health care costs by fostering greater price competition.

The takeaway

The ongoing stability of the biosimilar market depends on consistent legislative support for the FDA review framework. Patients should monitor future policy debates as these agreements directly influence the speed at which affordable alternatives reach the pharmacy shelf.