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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.