The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.
The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.
In his opening statement, Committee chair Representative Elijah Cummings, D-Maryland, said that drug companies’ price hikes to existing drugs and high launch prices for innovative products have created one of the biggest problems facing American families. Cummings called escalating prices unsustainable and a matter of life and death.
Among the experts providing testimony before the committee were Avik S.A. Roy, president of the Texas-based think tank The Foundation for Research on Equal Opportunity.
Roy testified that prescription drug use is the third largest component of US healthcare spending, despite the fact that the United States leads other advanced global economies in use of unbranded generic drugs, made possible through the Hatch-Waxman Act and its provision of a pathway for a US generic marketplace. High prices for branded drugs, he said, now outweigh efficient generic utilization. Roy pointed to patient price insensitivity and monopolistic pricing—resulting from a lack of competition for branded products like biologics—as drivers of this growth.
According to Roy, “subtle differences between Hatch-Waxman and the [Biologics Price Competition and Innovation Act, BPCIA], highly favorable to the pharmaceutical and biotechnology industries, have suffocated biosimilar competition.” In addition to questioning the longer exclusivity periods provided for biologics versus small-molecule drugs, Roy took issue with the fact that the BPCIA does not allow for automatic substitution of biosimilars at the pharmacy level unless they are granted interchangeable status by the FDA.
Roy also incorrectly stated that the BPCIA requires costly phase 3 clinical studies for biosimilars. The BPCIA does not, in fact, require phase 3 studies, and Coherus BioSciences’ pegfilgrastim biosimilar, Udenyca, was recently approved on the basis of analytical similarity studies as well as pharmacokinetic, pharmacodynamic, and immunogenicity studies.
Roy also pointed to patent issues—stating that patent litigation for biologics could exceed $100 million per product—and rebates paid by brand-name drug makers to pharmacy benefit managers as challenges to biosimilars.
Among Roy’s suggestions are reforms to the BPCIA that would allow for pharmacy-level substitution of biosimilars without interchangeable designations as well as government subsidies of legal costs for biosimilar developers who are challenging patents on originator products.
The committee also heard testimony from other experts, including Gerard F. Anderson, PhD, of the Johns Hopkins School of Medicine, who explained that drug makers may be gaming the Orphan Drug program to block competition for their products.
Similarly, Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, testified that patent exclusivities constitute government-granted monopolies on drugs and pointed to the example of Humira’s “patent thicket” that has forestalled US competition until 2023.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.