Lee Seeks Increased Competition in Biological Drug Market

July 13, 2023


WASHINGTON - Sens. Mike Lee (R-UT), Ben Ray Lujan (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduced the Biosimilar Red Tape Elimination Act to increase competition within the biological drug market and increase access to low-cost prescription drugs.


For small-molecule drugs, pharmacists can substitute generics in lieu of their branded counterparts. Access to generics is essential to increasing competition and bringing down the cost of prescription drugs for patients.


The generic equivalent of a biological drug is known as a biosimilar. Unlike generic drugs, many states will not allow pharmacists to substitute a biosimilar unless the FDA declares it to be “interchangeable.” The current process is cumbersome and expensive.


Under current regulations, acquiring interchangeable status requires the product to undergo switching studies - whereby participants must alternate between the biologic and the biosimilar – over and above the initial approval as a biosimilar. These studies can cost millions of dollars and further delay market access. After examining 15 years of data, the European Medicines Agency (EMA) recently stated that switching studies are unnecessary for biosimilars to obtain interchangeable status.


Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA. It also allows for use of switching studies in special circumstances. Eliminating the barrier of interchangeability would increase access to lower cost biosimilars and save payers and consumers billions over the next five years. It also allows for use of switching studies in special circumstances. Eliminating the barrier of interchangeability would increase access to lower cost biosimilars and save payers and consumers billions over the next five years. 


Of the bill, Sen. Lee said, “Our current regulatory environment imposes onerous and costly burdens that hinder the entry of biosimilars into the market. Ultimately, it's the patients who bear the brunt of limited competition and exorbitant drug prices. We owe it to them to break down these barriers and ensure they have timely access to these life-changing drugs.


 Of the bill, Sen. Lujan said, “Utilizing more biosimilar drugs will benefit patients and lower drug costs. But access is often limited because of the unique drawn-out process. This bipartisan legislation will streamline the approval process while maintaining patient safety and effectiveness. This change will help increase competition in the marketplace to ensure more patients and their families have access to medication that help treat diseases and other chronic conditions.


Of the bill, Sen. Braun said, “When there’s a lack of competition in the market, it’s the patients that suffer. In the Senate, I’ve been committed to expanding transparency and competition in the healthcare industry and this legislation would save Americans money by making sure that more biosimilars make it to market.” 



Read support for the Biosimilar Red Tape Elimination Act below:
The ERISA Industry Committee (ERIC) – President and CEO James Gelfand


On behalf of The ERISA Industry Committee (ERIC), representing the largest employers in the country, thank you for introducing the Biosimilar Red Tape Elimination Act.  This bill will unlock a barrier to much-needed FDA approvals of biosimilars, which hold the promise to provide access to quality medicines at affordable costs. ERIC has long-supported enhanced access to biosimilars to address increasing drug costs and the burden they carry on employers and their employees. This bill makes a commonsense change in law to hopefully open the ability of the FDA to expeditiously approve more biosimilars to bring to market, ultimately benefiting millions of American workers and their families.  ERIC strongly supports this bill and thanks Senators Lee and Luján for introducing the bill.”


Americans for Prosperity – Charlie Katebi, Senior Health Policy Analyst


Increasing generic alternatives empowers patients by creating lower cost options in the marketplace .says Charlie Katebi, Senior Health Policy Analyst, Americans For Prosperity. The Biosimilar Red Tape Elimination Act delivers this solution by removing unnecessary barriers, increasing the availability of lower cost generic biosimilar drugs, and providing patients a Personal Option for their prescriptions.


Lower Drug Prices Now- Margarida Jorge, Campaign Director


Biosimilars are an important part of lowering the cost of prescription drugs and are on track to save Americans tens of billions of dollars over the next five years. This bill by Senators Lujan and Lee will help cut red tape and safely bring more of these medications to market to create competition and lower prices.  We are proud to endorse and hope Congress will act on this vital legislation.


Prof. Dr. Sarfaraz Niazi


Prof. Dr. Sarfaraz K. Niazi, an expert on biosimilars with many peer-reviewed published papers and dozens of books on the subject of biosimilars, 100+ US patents, and multiple FDA-approved biosimilars, has also advised regulatory agencies and contributed to the amendment of the BPCIA to remove “animal toxicology” from the legislation.  According to Prof. Niazi, “an interchangeable status is given to a biosimilar after confirming that it has “no clinically meaningful difference, with the referenced product; it is difficult enough to demonstrate differences in clinical response between a biosimilar and its reference product, let alone to reconfirm it, an exercise that will require hundreds of thousands of patients to meet the FDA-required statistical criteria. As a result, none of these studies can ever fail. The safety issue in interchangeability testing is already resolved when biosimilars are approved. It is a sheer waste of resources and abuse of patients; it only helps large companies who can spend hundreds of millions of dollars to claim the superiority of their biosimilar product. EMA and MHRA allow interchangeability with the reference and other biosimilar products.”




BioUtah recognizes the aim of the Biosimilar Red Tape Elimination Act” to speed patient access to life-changing, lower-cost biosimilars by addressing regulatory inefficiencies. The legislation provides an avenue for discussion of the current U.S. interchangeability designation and how federal policy may impact the availability of biosimilars and affect costs to consumers. With a strong biopharma sector, Utah has led the nation in job growth in the life sciences industry since 2012, providing more than 42,000 jobs at more than 1,800 companies and generating $13 billion in GDP. Companies in our state are working to develop better treatments and new cures for devastating disease, such as cancer, MS, ALS and more. We appreciate the leadership of the bills sponsors, Senator Lee and Senator Lujan, in seeking to examine a more flexible pathway to market. We also look forward to working with the Senators and stakeholders to strike the right balance in advancing access to biosimilars while ensuring the safety and efficacy of these important medicines.”


Association for Utah Community Health (AUCH)


AUCH recognizes the need to improve the affordability of all components of healthcare, especially including the cost of pharmaceuticals. If enacted, the BRTEA could help reduce pharmaceutical prices through increased competition, particularly for costly biologics used to treat diseases such as Type 1 Diabetes and Rheumatoid Arthritis. AUCH is pleased that there is bipartisan interest in the BRTEA as this should help support its passage.”


Vizient - Shoshana Krilow, Senior Vice President of Public Policy and Government Relations


Requiring additional switching studies for biosimilars to be interchangeable is unnecessarily burdensome and limits competition. We should be creating policies to increase access to these lower cost biosimilars and the Biosimilar Red Tape Elimination Act is a significant step forward in doing just that,” said Shoshana Krilow, Senior Vice President of Public Policy and Government Relations for Vizient. “We appreciate Sens. Lee and Lujan for their leadership on this bipartisan bill and look forward to working together to advance the legislation.”


Dr. Jeffrey Hausfeld, Chairman of the Board and Chief Medical Officer – BioFactura, Inc.


The purpose of bringing biosimilars into the mainstream of US healthcare and the legislation supporting that evolution, should be focused on improving outcomes, quality of life, accessibility, and enhancing the patient experience, with medicines proven to be as potent, pure, safe, and effective as the branded drugs. The interchangeability status just creates a category which can be exploited to leverage continued mistrust in the technology, while adding no tangible value to the lives and well-being of patients entrusted to our care. Science is a universal language, and the same science is applied around the world, irrespective of a given sponsor’s business model, marketing strategy, or the ability to spend additional millions of dollars on interchangeability studies that have no proven benefit to healthcare outcomes. As a physician and Chairman of the Board of a biotech organization, I am in full support of this legislation.”


Dr. Sean J. Callahan, M.D., Associate Professor of Medicine, Pulmonary & Critical Care Medicine


I support the Biosimilar Red Tape Elimination Act introduced by Senator Lee. This legislation should improve market competition and reduce the cost of expensive medications for patients, particularly those with chronic conditions. It stands to help patients with pulmonary diseases, who often require these distinct therapies for treatment. As a provider who prescribes many of these costly medications I urge bipartisan support for this bill.


Beau Sorensen, COO – First Choice Home Health and Hospice


With healthcare costs continuing to increase, we are grateful for Senator Lee's leadership in helping patients get access to lower-cost biosimilar drugs by eliminating the red tape and unnecessary studies and steps that go into gaining FDA certification. Not only do we feel this will reduce costs for individuals, but it can also reduce overall costs for the Medicare program and taxpayers at large. This will be a huge help to our patients as they look to stay out of higher cost care settings through better access to affordable medications.


Pharmaceutical Care Management Association (PCMA)


PCMA applauds Sens. Mike Lee and Ben Ray Lujan’s bipartisan legislation which would accelerate biosimilar uptake in the United States by reducing complexity. Pharmacy benefit companies strongly support the removal of barriers that for too long have suppressed the biosimilars market. This measure will increase competition for biologic drugs, providing added choice and flexibility for health plan sponsors and employers and allow pharmacy benefit companies to leverage this enhanced competition to further reduce drug costs.


Prime Therapeutics Letter


Although biologics comprise approximately 3% of prescriptions in the U.S., these products account for over half of prescription medicine spending. Biosimilar drugs cost less and show no clinically meaningful difference from biologic drugs. Over the next five years, savings from biosimilars are expected to exceed $180 billion, representing a four-fold increase over the savings from the previous four years, according to a recent insurance study. The Biosimilar Red Tape Elimination Act will make it easier to realize these projected savings. By deeming all biosimilars as interchangeable upon FDA approval, this important legislation would make it easier, depending on state law, for pharmacists to substitute biosimilars for brand products thus removing an important barrier to biosimilar uptake. This move would reduce complexity for pharmacies, prescribers, and patients, thereby reducing barriers to biosimilar dispensing.”    


HSA Coalition Letter


The Biosimilar Red Tape Elimination Act would streamline the biosimilar approval pathway and ensure that all approved biosimilars are deemed interchangeable, while respecting states' rights to regulate biosimilar substitution. By removing unnecessary obstacles, we can ensure wider market access and increase trust in these important medications, while reducing drug costs for consumers. We believe that this legislation aligns with biosimilar efficacy and safety and supports our shared goal improving the affordability of healthcare for all Americans.”




Hiologics deeply appreciates Senator Mike Lee's pioneering Biosimilar Redtape Elimination Act, an essential step in improving patient access to affordable, effective biosimilar drugs. This legislation streamlines the FDA certification process and promotes market competition, enabling significant cost savings and overcoming key challenges that have  hampered the full potential of biosimilars.”


For full text of the bill, click HERE.

For a two-pager on the bill, click HERE.