Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

September 11, 2023

The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B. This shortsighted move won’t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM.

IRA Changes Break a Successful Program
Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services, worked on the development and implementation of the Part D prescription drug benefit during his six years in the Secretary’s Office. While proponents of government price-setting in Medicare claim this will create savings and lower costs, Reilly disagrees:

“Part D was designed following two decades of experience seeing government price-setting fail to control Medicare costs for services and healthcare provider rates. To avoid this happening with the new prescription drug benefit, we created a new model. Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. It has a 90% approval rating among beneficiaries^[1], premiums have held steady around $32/month since 2006, and it holds the distinction of being the only major federal program to ever come in under budget.”

A Better Reform: Ensuring Savings Are Passed Onto Patients
While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains. “Part D has been hugely successful in lowering costs- but these savings are not always being passed on to the patient by the PBMs. Thankfully, there is a broad bipartisan effort underway in Congress to rectify this and provide immediate relief for patients- this year, not in 2026.” No fewer than eight bills have been introduced or advanced out of committee this session, with bipartisan support, to address PBM rebate and pricing policies that result in higher drug prices for patients.

The Consequences of European-style Drug Price-Setting Policies

Not only will it fail to control costs, imposing European-style price controls on Medicare Part D will spell disaster for American patients in the coming years. Reilly remarks, “The U.S. leads the world in drug innovation and patient access precisely because we’ve rejected the kind of price controls that stifle R&D and delay drug availability in Europe and Asia.” For example:

In the 1970s, European companies developed most new drugs; however, since the implementation of price controls in Europe, U.S. companies now produce 60% of new drugs, while European countries often have percentages in the single digits.^[1]
90% of new cancer drugs are available in the U.S. within the first year, whereas fewer than half are available to cancer patients in Germany, the UK, France, and Canada^[2]
European cancer death rates are 1.7 times higher than in the U.S.^[3]

Reilly describes what European-style health outcomes might look like in the U.S: “Imagine if the U.S. had European cancer death rates. That would translate to an extra 420,000 cancer deaths annually. Europe’s drug price-setting is simply not a policy worth emulating, and American patients should be aware of its public health consequences.”

ASBM Leading Education Efforts
ASBM has submitted comments to CMS critical of the policy and is conducting an educational campaign about the policy’s harmful effects. On July 26^th, ASBM hosted a webinar with the Generics and Biosimilars Initiative (GaBI) to examine the price-setting policy’s impact on drug development and reduced patient access to new medicines. The event featured three former government officials who were instrumental in the development of Medicare Part D’s prescription drug benefit; as well as experts from the fields of cancer drug research and patient advocacy, each of whom voiced their strong concerns with the policy individually and in a panel discussion.

ASBM also maintains an educational microsite for the patient community at IRAPatientInfo.org

The Alliance for Safe Biologic Medicines (ASBM) is a diverse group of stakeholders that includes physicians, pharmacists, patient advocates, researchers, and biopharmaceutical manufacturers. Since 2010, ASBM has worked closely with regulators worldwide as they develop and implement health policies, to ensure that these reflect the best interests of patients.

^[1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021

^[2] IQVIA Analytics, FDA, EMA, PMDA, TGA, & Health Canada data, April 2021.

^[3] “Democrat plan on drug costs will stifle innovation”, San Antonio Express-News, May 12, 2021

^{^[1]} https://www.usatoday.com/story/onpolitics/2012/10/03/poll-medicare-prescription-drug-program-popular/1609995/

January 2025 Newsletter

March 10, 2025

ASBM Statement on CMS Announcement of 15 Additional Drugs Subject to Government Price Controls On January 17th, the Centers for Medicare & Medicaid Services (CMS) announced an additional 15 drugs that will be subject to price controls under the Inflation Reduction Act (IRA). This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. “The IRA’s drug price controls are already hindering investment in critical drug research and development, undermining the innovation that has long made the U.S. a global leader in biopharmaceutical breakthroughs,” said Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services. The consequences of the IRA’s “small molecule penalty,” which limits the time manufacturers have to recoup investments in simpler “small molecule” drugs like pills, are already being felt. Small molecule drugs make up over 90% of prescriptions filled in the U.S. and are essential for treating conditions such as cancer, heart disease, and neurological disorders. Yet, since the IRA’s implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law. “By disincentivizing the development of these breakthrough therapies, the IRA puts the health of millions of patients at risk, now and in the future,” Reilly stated. Recent analyses underscore the harmful impact of the IRA’s policies. A recent IQVIA analysis of the first 10 drugs selected for price controls found that the federal government’s projected $6 billion in Medicare savings was overstated and misleading. Instead of reducing costs for patients, these price-setting measures are expected to increase out-of-pocket expenses for many beneficiaries. “ Read the full statement here.

Dr. Christina Beato: Lowering Interchangeable Biosimilar Standards Risks Patient Health, Physician Confidence On January 17th, the Albuquerque Journal published an op-ed by Dr. Christina Beato, former Assistant Secretary for Health and Human Services (HHS) on the topic of interchangeable biosimilar standards. In the piece, Dr. Beato shares her concerns with the recent policy push in Congress and the outgoing Administration to deem all biosimilars “interchangeable” upon approval, without additional data demonstrating the switch would not jeopardize patient stability, as is currently required. From the op-ed: Physicians overwhelmingly oppose these types of policies, and for good reason. A recent survey of doctors who prescribe biosimilars found that only 11% of physicians believe all biosimilars should be deemed “interchangeable.” Nearly 90% of doctors value the rigorous FDA review process for determining interchangeability and believe that the required studies are particularly important in building their confidence in biosimilar substitution. As a New Mexico physician and a former official at the U.S. Department of Health and Human Services (HHS), I was disheartened to learn that U.S. Sen. Ben Ray Luján, D-New Mexico, has supported efforts to loosen biosimilar standards. We must take steps to reduce health care costs, but cutting corners on safety protocols is not a solution. It’s a recipe for eroding quality, equity, and trust in our health care system. Patients deserve better, and New Mexicans expect their leaders to stand up for policies that protect their health and safety rather than undermine them. The current FDA standards for biosimilars have achieved a delicate balance of promoting innovation and equitable access to affordable treatments while maintaining high standards of safety and efficacy. This balance has given both patients and physicians the confidence to embrace these new medicines. Policies that override these standards threaten to unravel years of science-based progress. Read the full op-ed here.

RFK Jr., Nominee for Secretary of Health and Human Services, Advances in Confirmation Process Robert F. Kennedy Jr., President Trump’s nominee for Secretary of Health and Human Services, has successfully advanced past the Senate Finance Committee with a narrow 14-13 vote. He now faces a full Senate vote. Some of Kennedy’s stances- such as his support for an examination of the safety of ultra-processed foods, as well as synthetic dyes and additives- have garnered widespread support. However, the nominee has also received criticism about his views on other health policies such as vaccine safety. Kennedy has insisted that he is not “anti-vaccine” and has pledged not to ban vaccines under Trump. Kennedy has maintained that rather than banning vaccines, he intends to push for greater transparency surrounding their safety data. Read more about what to expect in the full Senate vote here.

New FTC Report Details How PBMs Inflate Drug Costs On January 14th, the Federal Trade Commission (FTC) released a second interim report highlighting alarming practices by the nation’s three largest pharmacy benefit managers (PBMs)—Caremark, Express Scripts, and Optum Rx. The report revealed dramatic price increases for specialty generic drugs, with some seeing markups of thousands of percent. These findings underscore the growing calls by patient advocacy organizations, physicians, and others for reform of controversial PBM rebate and formulary design practices criticized for driving up healthcare costs and restricting access to affordable medications. Key findings in the report show that the “Big 3” PBMs generated over $7.3 billion in excess revenue from specialty generic drugs between 2017 and 2021, achieving a staggering annual growth rate of 42%. Additionally, PBM-affiliated pharmacies were reimbursed at significantly higher rates than independent pharmacies, further disadvantaging unaffiliated competitors.The report also noted that plan sponsors paid $4.8 billion for specialty generics in 2021, while patient cost-sharing soared to $297 million. This report follows mounting federal scrutiny of PBMs, including congressional hearings and a prior FTC investigation and lawsuit over their role in inflating drug costs and undermining independent pharmacies. Read the FTC Report here.

PBM Reform: Could 2025 Finally See a Long-Awaited Overhaul? After years of mounting pressure from a broad coalition of stakeholders including patients, physicians, pharmacists, and pharmaceutical manufacturers, meaningful reform for Pharmacy Benefit Managers (PBMs) finally seemed within reach this past December. A federal funding bill originally included sweeping measures to mandate rebate transparency, prohibit overbilling Medicaid, and pass savings to Medicare sponsors—provisions that could have fundamentally reshaped the industry. However, the greatly stripped-down bill that was ultimately passed did not include these much sought-after changes, leaving reform advocates disappointed and the healthcare system unchanged. As PBMs face increasing scrutiny from lawmakers, regulators, and the public, 2025 presents another chance to address their controversial practices. With bipartisan momentum behind legislation like the PBM Act (which would force PBMs to sell their pharmacy assets) and ongoing Federal Trade Commission (FTC) lawsuits targeting industry giants over insulin pricing, could 2025 be the year that reform finally happens? A January 6th article in PharmaVoice takes a deep dive into how Congress and various regulatory agencies might rein in PBM practices in the coming year, and what a post-PBM reform drug distribution system might look like. Read the full story here. ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA On February 20th, Philip Schneider, ASBM Advisory Board Chair, will teach a 2-hour class at the Ohio State University College of Pharmacy that examines how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry. The module will examine three current policy issues related to biosimilars:The likely negative impact of the Inflation Reduction Act’s price-setting on biosimilar development and commercialization;
Proposed legislation (such as last year’s Biosimilar Red Tape Elimination Act) which would lower the requirements for interchangeable biosimilars and/or declare all biosimilars interchangeable and thus pharmacy-substitutable; and
Various efforts to reform Pharmacy Benefit Manager (PBM) utilization management and formulary design practices. Pharmacy students will be given basic information about each proposal, then asked to research further and discuss challenges each policy might pose to increasing patient access to safe and affordable therapies. The course is the latest collaboration between ASBM and the OSU College of Pharmacy; which has included a 7-part comprehensive series on biosimilars, led by Professor Schneider and featuring ASBM Chairman Ralph McKibbin, MD; Immediate Past Chair Madelaine Feldman, MD, and ASBM Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association. What Will 2025 Mean for Medicare Drug Price Setting Under the IRA? The Inflation Reduction Act’s (IRA) Medicare drug price negotiation program, while aimed at reducing costs, could have unintended consequences that reshape the pharmaceutical landscape. According to an article published January 10th in the legal news site JD Supra, the Maximum Fair Prices (MFPs) mandated under the IRA, with reductions as steep as 79%, could lead to ripple effects far beyond Medicare. Analysts warn of “spill-over” impacts on the private commercial market, as pharmacy benefit managers adjust formularies to compensate for reduced rebates. Moreover, the IRA may stifle innovation, with some companies cutting research pipelines and abandoning plans for follow-on drug indications.The law’s aggregation rules, which combine all drugs sharing an active ingredient under a single negotiation umbrella, further disincentivize investment in new formulations. The authors argue these provisions could “dampen incentives for additional research,” leaving patients with fewer treatment options in the long term. Manufacturers and patient advocacy organizations have challenged the IRA’s negotiation program through various legal claims, including First and Fifth Amendment challenges, but most cases have been dismissed on procedural grounds. However a 5th Circuit decision in September 2024 allowed a key case to proceed based on claims of economic harm and lack of proper notice-and-comment procedures, suggesting that litigation over the IRA could continue for years. In addition, with an incoming Republican administration and majorities in Congress, some provisions of the IRA may be up for debate. While a complete repeal of the law is unlikely, lawmakers could target controversial elements like the “orphan drug exclusion,” which discourages companies from expanding treatments for rare diseases, and the so-called “small molecule penalty,” which may disincentivize small molecule drug development. For more on the IRA’s evolving impact, read the full article here. Learn more about the IRA’s likely effects on patients at IRAPatientInfo.org ICYMI: Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients. The bill would classify all biosimilars as interchangeable, allowing them to be substituted at the pharmacy level without physician approval, as if they were generics (which they are not). It would also remove the FDA’s authority to ask for additional studies when needed. Currently, biosimilar sponsors must demonstrate to the FDA that switching will not affect treatment safety or efficacy before third parties like insurers or pharmacy-benefit managers (PBMs) can substitute a biosimilar. The bill would remove these guardrails, Reilly explains: However, if passed, the Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable without requiring additional analysis or data. Insurers and pharmacy benefit managers (PBMs) nationwide would be able to switch patients to their preferred – and often most profitable – products regardless of “interchangeable” designation. Inappropriate switching may affect treatment stability and safety for patients. Proponents of the bill have continuously cited alarming factual errors that suggest even the sponsors do not understand the science or the implications of this policy. The sponsors have falsely claimed that biosimilars are “equivalent” to generics; yet the FDA says, “biosimilars are not generics and important differences exist between them.” Supporters of the bill claim that clinical switching studies are required to substitute interchangeable biosimilars at the pharmacy when, in fact, the FDA has broad discretion on what data is required. A majority of interchangeable biosimilars were approved without such studies. Additionally, supporters of this bill incorrectly claim that loosening the standards for interchangeability will align U.S. policy with Europe. Contrary to what supporters of the bill claim, this policy will not align U.S. biosimilar regulations with those in Europe. The European Medicines Agency (EMA) refers to “interchangeability” as prescription substitutions by physicians and not third-party substitution of biosimilars at the pharmacy counter – a practice that is rare and frequently banned in European countries. U.S. physicians, who are experts in prescribing these treatments, overwhelmingly oppose the bill’s provisions. A recent survey found that 88% support individual evaluations for biosimilar interchangeability, and the same percentage see switching studies as essential to increasing confidence in these medicines. Only 11% of physicians support the FDA deeming all biosimilars as interchangeable without further data, as this bill would mandate. Read the full op-ed here.

FDA Approves a Record-Breaking 18 Biosimilars in 2024 In December 2024, the FDA approved its 63rd biosimilar, Steqeyma (Ustekinumab-stba). Steqeyma is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. The approval of Steqeyma brings the total number of biosimilars approved in 2024 to 18, a record for the FDA. Eight of these approvals were for biosimilars whose reference products previously had no biosimilar competition. Read about the approval here.
View all approved FDA biosimilars here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS WHO 80th INN Consultation
Geneva, Switzerland – March 18-21, 2025 DDNC Annual MeetingLos Angeles, CA – May 17-21, 2025 ASCO Annual MeetingChicago, IL – May 30-June 3, 2025 DIA Global Annual Meeting
Washington, DC – June 15-19, 2025 BIO International Convention
Boston, MA – June 16-19, 2025

Fact Sheet: the IRA’s “Pill Penalty”

March 7, 2025

Click below to read ASBM member WeWorkForHealth’s Fact Sheet on the effects of the IRA’s “Pill Penalty”, also known as the “Small-Molecule Penalty”, which disincentivizes R&D on chemically-derived medicines used to treat many serious conditions like cancer and heart disease:

Click below to view

November-December 2024

February 5, 2025

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients. The bill would classify all biosimilars as interchangeable, allowing them to be substituted at the pharmacy level without physician approval, as if they were generics (which they are not). It would also remove the FDA’s authority to ask for additional studies when needed. Currently, biosimilar sponsors must demonstrate to the FDA that switching will not affect treatment safety or efficacy before third parties like insurers or pharmacy-benefit managers (PBMs) can substitute a biosimilar. The bill would remove these guardrails, Reilly explains: However, if passed, the Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable without requiring additional analysis or data. Insurers and pharmacy benefit managers (PBMs) nationwide would be able to switch patients to their preferred – and often most profitable – products regardless of “interchangeable” designation. Inappropriate switching may affect treatment stability and safety for patients. Proponents of the bill have continuously cited alarming factual errors that suggest even the sponsors do not understand the science or the implications of this policy. The sponsors have falsely claimed that biosimilars are “equivalent” to generics; yet the FDA says, “biosimilars are not generics and important differences exist between them.” Supporters of the bill claim that clinical switching studies are required to substitute interchangeable biosimilars at the pharmacy when, in fact, the FDA has broad discretion on what data is required. A majority of interchangeable biosimilars were approved without such studies. Additionally, supporters of this bill incorrectly claim that loosening the standards for interchangeability will align U.S. policy with Europe. Contrary to what supporters of the bill claim, this policy will not align U.S. biosimilar regulations with those in Europe. The European Medicines Agency (EMA) refers to “interchangeability” as prescription substitutions by physicians and not third-party substitution of biosimilars at the pharmacy counter – a practice that is rare and frequently banned in European countries. U.S. physicians, who are experts in prescribing these treatments, overwhelmingly oppose the bill’s provisions. A recent survey found that 88% support individual evaluations for biosimilar interchangeability, and the same percentage see switching studies as essential to increasing confidence in these medicines. Only 11% of physicians support the FDA deeming all biosimilars as interchangeable without further data, as this bill would mandate. Read the full op-ed here.

ASBM Responds to PBM Industry Endorsement of Biosimilar Red Tape Elimination Act On December 9th, ASBM released a statement in response to the recent call by the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers (PBMs), that urged passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035). ASBM has consistently opposed the bill, which would eliminate the FDA standards biosimilars must currently meet in order for third-parties like PBMs to substitute them at the pharmacy level. This change would lead to widespread third-party substitution of all biosimilars, jeopardizing treatment stability for millions of patients and undermining physician confidence in biosimilar substitution. From the statement:The Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.Read the full statement here.

ASBM Exhibits at ACR Convergence 2024 During November, ASBM was proud to again participate in the American College of Rheumatology (ACR) Convergence 2024, held from November 14-19 in Washington, DC. ACR Convergence is known as the world’s premier annual rheumatology gathering. ASBM exhibited in the conference’s patient pavilion from November 15-18, and was represented at the meeting by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude. ASBM’s booth featured a variety of materials ASBM has developed over the past year on issues including interchangeable biosimilars and the Inflation Reduction Act; as well as a monitor playing recent ASBM webinars on these and other topics. Joining ASBM as exhibitors were ASBM member organizations including the Lupus and Allied Diseases Association (LADA) and Ai Arthritis. Read more about ACR Convergence 2024 here.

FDA Approves 63rd Biosimilar, Its 17th in 2024 In December, the FDA approved its 63rd biosimilar, Steqeyma (Ustekinumab-stba). Steqeyma is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. The approval of Steqeyma brings the total number of biosimilars approved in 2024 to 17. Read about the approval here.
View all approved FDA biosimilars here.

ASBM Resource Recap: Biosimilar Red Tape Elimination Act As a part of ASBM’s ongoing educational efforts surrounding S.2035, the Biosimilar Red Tape Elimination Act, we have recently released several resources for policymakers and the general public. These include:A Myth vs. Fact sheet which highlights several serious factual errors and misinformation used in efforts to promote and gain support for the bill. Op-ed from ASBM Executive Director Michael Reilly (RealClearHealth)Op-ed from ASBM Chairman Ralph McKibbin MD (Altoona Mirror)An October 31st Webinar ASBM/Generics and Biosimilar Initiative For more ASBM educational materials on the Biosimilar Red Tape Elimination Act click here.

Missed last month’s ASBM Newsletter?Read it here.

ASBM Responds to PCMA: Put Patients First, Not PBM Profits

December 12, 2024

Press Release

ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.

The bill would automatically declare all biosimilars as “interchangeable” with their reference biologics. Currently, manufacturers must demonstrate to the FDA that switching between their biosimilar and the reference biologic will not reduce safety or efficacy, jeopardizing patients’ treatment stability. If enacted, the bill would also overrule laws in all 50 states limiting pharmacy substitution to interchangeables. The state laws were widely supported by state medical societies and patient advocacy organizations, their support conditioned on the reassurances provided by the scientific standards the pending legislation would eliminate.

“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”

Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.

When informed of the proposal, physicians overwhelmingly oppose it. A recent survey of 270 U.S. biologic prescribers revealed:

Only 11% support automatically classifying all biosimilars as interchangeable.
88% believe biosimilar switching studies increase their confidence in the safety of biosimilar substitutions.
69% agree that decisions about switching should remain between patients and their doctors, not insurers or pharmacies.

These findings underscore the widespread physician concern that the legislation undermines their ability to provide safe, personalized care. Indeed, 40 physician organizations recently sent a letter to Congress questioning the bill’s likelihood of increasing biosimilar access, and suggesting alternative ways to promote biosimilar uptake. The letter noted that “commercial plans including Medicare Advantage pay no attention to the interchangeability of a biosimilar when constructing formularies” [the list of covered medicines], they consider “only the size of rebates and fees collected.”

“Congress must prioritize patients over profits by retaining the rigorous standards that have earned physician trust and protected patients for nearly a decade,” said Reilly. “If policymakers truly want to promote biosimilar uptake, they should explore alternate pathways – ones that don’t erode safety standards, undermine physician confidence or risk destabilizing patient treatment plans.”

Media Contact:
Michael Reilly
media@safebiologics.org
(202) 222-8326

September-October 2024

November 14, 2024

SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st

On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S. biosimilar approval and substitution policies, discuss the rationale behind them, and examine the potential consequences of the proposed changes. Healthcare practitioners and patient advocacy representatives will also share their concerns about the Biosimilar Red Tape Elimination Act’s effects on physican confidence in biosimilars and its potential to jeopardize treatment stability for patients nationwide.

More details and the program agenda will be made available soon.

Read more about physician concerns with S.2305 here.

Dr. McKibbin Op-ed: Lowering the Interchangeable Biosimilar Standard Endangers Patient Health On October 3rd, an op-ed by ASBM Chairman Ralph McKibbin MD ran in the Pennsylvania-based Altoona Mirror. In the article, Dr. McKibbin highlights physician concerns with Senate Bill 2035, the “Biosimilar Red Tape Elimination Act”, under consideration by the Senate Committee on Health, Education, Labor, and Pensions (Senate HELP). The U.S. physicians who prescribe biologic medicines, however, do not support the bill’s provisions, McKibbin explains: The Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable, allowing insurance companies to switch patients to any biosimilar without prior physician approval — even if it hasn’t been demonstrated to the FDA that such switching won’t jeopardize treatment stability.
The bill would also effectively strip the FDA of its ability to request studies on switching, weakening the standards that currently protect patients.
It’s no surprise that doctors across the country overwhelmingly oppose these changes. A recent survey of 270 U.S. physicians who prescribe biologics found that only 11% support classifying all biosimilars as interchangeable, and 88% believe that switching studies increase their confidence of safely switching their patients to biosimilars.
As physicians, our primary concern is our patients’ health and safety.It is Congress’s responsibility to maintain the rigorous standards for biosimilar interchangeability that have protected patients, earned doctors’ trust, and saved our healthcare system $24 billion.

Read the full op-ed here.

ASBM’s Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards On September 25th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly, discussing widespread physician opposition to key components of S.2305, “The Biosimilar Red Tape Elimination Act”, which would declare all biosimilars interchangeable and thus, substitutable at the pharmacy level by insurance companies and PBMs. State medical societies nationwide support the laws now permitting the substitution of interchangeable biosimilars. However, that support was conditional on assurances from policymakers that third-party substitution would be limited only to interchangeable biosimilars backed by additional safety and efficacy data.
But the safeguards physicians count on may soon be removed. This week, the Senate HELP Committee, which includes my own senator, Tim Kaine of Virginia, will vote on a bill that would classify all biosimilars as interchangeable. It would permit insurance companies to switch patients to any biosimilar as if they were generics, removing prior physician approval, in absence of now-required data demonstrating that switching won’t reduce safety and efficacy. The Biosimilar Red Tape Elimination Act would also remove the FDA’s ability to ask for switching studies when appropriate, dangerously lowering current safety standards. If this bill becomes law, it could negatively impact treatment stability for millions of patients. Reilly cited the findings of ASBM’s recent survey of 270 prescribers of biologic medicines. That survey revealed that only 11% support declaring all biosimilars interchangeable. 88% said switching studies increased their confidence in safe biosimilar substitution. The survey results come at a time when the interchangeable biosimilar standard faces several policy challenges. In August, ASBM shared the findings with the FDA as part of a public comment period on Draft Guidance that would de-emphasize switching studies. Read the full op-ed here. Read the U.S. physician survey here and the press release about its findings here. Read more about S.2305 here.

ASBM Chairman Discusses Interchangeable Biosimilar Policy at Washington, DC Policy Forums On September 23rd and 24th, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF visited Washington, DC to participate in two policy forums at which he shared physician perspectives on biosimilars policy. The first event was a 2024 Fall Policy Forum hosted on Capitol Hill by the Digestive Disease National Coalition (DDNC). The meeting was attended by Hill staff and key lawmakers who work on health policy. Attendees included Representatives Jim McGovern (D-MA) and Buddy Carter (R-GA). Representative Carter is a pharmacist and member of the House Energy & Commerce Committee’s Health Subcommittee. Dr. McKibbin used the meeting as an opportunity to share results of ASBM’s recent physician survey, showing strong opposition to S.2305, “The Biosimilar Red Tape Elimination Act” (see above articles) which would declare all biosimilars interchangeable and thus, substitutable at the pharmacy level by insurance companies and PBMs. The following day, Dr. McKibbin participated in a panel discussion entitled “the Changing Landscape of Biologics”, as part of the Alliance for Patient Access’ (AfPA’s) 9th Annual Policy & Advocacy Summit. McKibbin provided the physician perspective on a variety of topics including interchangeable biosimilar and substitution policy, non-medical switching, and the continued need for physician reimbursement and Pharmacy Benefit Manager (PBM) reforms. View Dr. McKibbin’s panel discussion here.

ASBM Letter to US Senate Details Overwhelming Physician Opposition to “Biosimilar Red Tape Elimination Act” On September 6, ASBM sent a letter to Senator Mike Lee (R-UT), sponsor of Senate Bill 2305 (S.2305), the “Biosimilar Red Tape Act”. The letter was also sent to cosponsors of the bill, including Sen. Mike Braun, (R-IN), Sen Ben Ray Lujan (D-NM), Sen. Rand Paul (R-KY), and Sen. JD Vance (R-OH). The letter details the opposition among U.S. physician opposition to key components of S. 2305. These include a provision that the FDA designate all biosimilars as interchangeable (and thus substitutable like generics- without physician involvement- at the pharmacy level by third parties such as insurance companies and pharmacy benefit managers (PBMs). The bill also removes the FDA’s authority to consider switching studies when making a determination that safety and efficacy do not diminish following a biosimilar substitution. From the letter: The letter shared survey data from ASBM’s August survey of 270 physicians, which showed strong opposition to key provisions of S.2305. For example, only 11% of physicians supported making all biosimilars interchangeable, as the bill would. In addition, 88% said that switching studies- showing no loss of efficacy or safety- increased their confidence in an interchangeable biosimilar being substituted. S. 2035, however, would remove the FDA’s ability to consider such studies during biosimilar approval. Read the letter to Sen. Lee and the bill’s cosponsors here. Read more about S. 2035 here. Read ASBM’s physician survey here and the press release about its findings here.

ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA On September 30, Philip Schneider, ASBM Advisory Board Chair, taught a 2-hour class at the University of Colorado-Boulder’s College of Pharmacy entitled “Biosimilar Medicines”. The course examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry. The module examined three current policy issues related to biosimilars:The likely negative impact of the Inflation Reduction Act’s price-setting on biosimilar development and commercialization;
Senate Bill 2035 (the Biosimilar Red Tape Elimination Act) which would lower the requirements for interchangeable biosimilars and/or declare all biosimilars interchangeable and thus pharmacy-substitutable; and
Various efforts to reform Pharmacy Benefit Manager (PBM) utilization management and formulary design practices. Pharmacy students were given basic information about each proposal, and then asked to research further and discuss challenges each policy might pose to increasing patient access to safe and affordable therapies. In February 2025, Schneider will offer a version of the course at Ohio State University’s College of Pharmacy, where he is a professor of pharmacy. ASBM and the OSU College of Pharmacy recently collaborated on a 7-part comprehensive series on biosimilars, led by Professor Schneider and featuring ASBM Chairman Ralph McKibbin, MD; Immediate Past Chair Madelaine Feldman, MD, and ASBM Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association. The ACPE-accredited course is worth 7 hours of continuing education credit and is open to all pharmacists nationwide and may be accessed here.

ASBM and GaBI Present Webinar on the Biosimilar Red Tape Elimination Act

On October 31st, ASBM and the Generics and Biosimilar Initiative presented a webinar focusing Senate Bill 2305 (S.2305) the Biosimilar Red Tape Elimination Act. Currently, state laws nationwide permit only “interchangeable” biosimilars to be automatically substituted by insurers of pharmacy-benefit managers (PBMs), the way generics may be substituted- without physician approval. Whil safe and effective, unlike generics biosimilar are not identical to their reference products. To earn the interchangeable designation, manufacturers of these biosimilars must demonstrate to the FDA that switching a patient will not reduce safety or efficacy of treatment, through additional data that sometimes including switching studies. The bill would for the first time permit widespread and unrestricted pharmacy-level substitution of all biosimilars, inappropriate treating them as generics for substitution purposes.

During the webinar, ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider reviewed current U.S. biosimilar approval and substitution policies, discussed the rationale behind them, and examined the potential consequences of the proposed changes.
Reilly, who recently co-authored a whitepaper about how misinformation is distorting U.S. interchangeable biosimilar policy, highlighted multiple misconceptions underpinning the bill, performing a “fact check” on several inaccuracies in a press release announcing its introduction.
For example, the bill’s press release stated that biosimilars are equivalent to generics and that switching studies are required for approval as interchangeable. In reality, the FDA has said that “biosimilars are not generics and important difference exist between them” and that they “were able to approve the majority of interchangeable biosimilars without clinical switching studies.” In addition, the press release stated that the European Medicines Agency (EMA) determined that switching studies are not necessary for interchangeability, inaccurately suggesting that S.2305 would align the U.S. with European policy. In reality, the EMA has said its use of the term refers to substitution of biosimilars by the prescribing physician, not automatic pharmacy-level substitution of biosimilars, a practice banned in much of Western Europe and not within the remit of the EMA.
ASBM Chairman Ralph McKibbin MD shared concerns that physicians have with the Biosimilar Red Tape Elimination Act. A recent survey of 270 U.S. physicians revealed only 11% support all biosimilars being deemed interchangeable. ASBM Steering Committee Member Andrew Speigel, Executive Director of the Global Colon Cancer Association, shared patient concerns about the Bill. In particular, Spiegel stressed the potential of the unprecendented large-scale third-party substitution the bill would unleash to jeopardize treatment stability for patients nationwide.
More details and the program agenda will be made available soon.
View the webinar here.

ASBM Presents at 79th WHO INN Consultation
On October 22nd, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 79th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland.
ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO.
However, the Executive Summary from the 78th INN Consulation (held March 18, 2024 and at which ASBM also presented) lays out the benefits of a distinct global nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators:
The ASBM intends to defend the role of clinical data in biosimilar approval and this trend toward deemphasis of clinical data in biosimilar approval also makes strong post-marketing pharmacovigilance all the more important.
The benefits of a WHO led distinct nomenclature standard remain clear and would benefit the least economically-developed countries of the world. The meeting was reminded of previous ASBM studies that show strong support for distinct naming including regulators in large and small countries. Some regulators have adopted their own specific naming system and some who initially supported the BQ have initiated their own system would be happy to adopt a WHO global standard.
In summary, as the INN Group still supports its recommendation for distinct suffixes, as strong support for distinct naming remains amongst regulators and as lead regulators push for reduced emphasis on clinical trials in biosimilar approvals and stronger biologic pharmacovigilance becomes increasingly important, ASBM is determined to advance the proposal by working with the WHO and other National Regulatory Authorities worldwide.
Read the full Executive Summary of the 78th INN Consultation here.

Missed last month’s ASBM Newsletter?Read it here.

Myth vs Fact: The Biosimilar Red Tape Elimination Act

November 14, 2024

Click here to download the Myth vs Fact Onepager.

ASBM Physician Survey on Interchangeable Biosimilars Finds Support for Maintaining Current Standards

October 13, 2024

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

FOR IMMEDIATE RELEASE– September 4, 2024
Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic medicines they copy, according to a recent survey of 270 U.S. physicians. The August 2024 survey, conducted on behalf of the Alliance for Safe Biologic Medicines, documents the perspectives of specialists from nine practice areas in which biologic medicines are routinely prescribed, including gastroenterology, oncology, rheumatology, and others.

“All FDA-approved biosimilars are safe and effective, but treatment plans are not universal or “one-size-fits-all”, explains ASBM Chairman Ralph McKibbin, MD. “Each is uniquely tailored, and patients frequently try several products before finding one that best stabilizes their condition. Physicians need to be confident that a substitution by a pharmacy or insurance company won’t disrupt a patient’s hard-won treatment stability. The interchangeable standard’s rigorous data requirements, often including switching studies, provide that assurance.”

Key Findings from the Survey:

88% of physicians agree that switching studies increase their confidence in the safety of switching patients from an originator medicine to an interchangeable biosimilar
87% of physicians prefer switching patients to a biosimilar only if it has been rigorously evaluated for its impact on safety and efficacy when switched from an originator biologic.
88% believe an interchangeable biosimilar should undergo individual evaluations to determine the impacts of switching on patient safety and efficacy.
Only 11% of respondents are in favor of deeming all biosimilars as interchangeable without these evaluations.
85% agree that biosimilars should only be considered interchangeable if they have been specifically assessed for safety and efficacy in switching scenarios.

In the U.S. as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. But because biosimilars are not identical to their reference products, pharmacy substitution is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. Under U.S. state laws, only biosimilars deemed “interchangeable” by the FDA may be substituted at the pharmacy without physician involvement the way generic drugs are. “These laws were passed with the support of state medical societies nationwide, which was conditional on pharmacy substitution being limited only to interchangeable biosimilars”, notes ASBM Executive Director Michael Reilly.

The survey’s results are consistent with prior surveys, says Reilly: “A 2021 survey revealed that while 89% of U.S. physicians are confident in the safety and efficacy of biosimilars; 69% believe only the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. But the majority (59%) are more comfortable with a pharmacy-level substitution of an interchangeable because of the additional safety and efficacy data currently required. The FDA’s standards are working. Any effort to lower them could compromise the progress we’ve made in building physician and patient confidence in biosimilars.”

ASBM shared the survey findings with the FDA as part of a public comment period on draft guidance that proposes to lower the data requirements for demonstrating interchangeability. The U.S. Senate is also considering a bill that would deem all biosimilars interchangeable and severely restrict the FDA’s ability to ask for additional data.

###

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization of patients, healthcare providers, and manufacturers committed to ensuring that biosimilar medicines are introduced in the U.S. in a patient-centered way with transparent policies based on sound science and effective regulation. Learn more at www.SafeBiologics.org

Dr. McKibbin Op-ed: Lowering Interchangeable Biosimilar Standards Endangers Patient Health

October 5, 2024

Lower med standards endangers health

Altoona Mirror

Opinion

Oct 2, 2024

Dr. Ralph McKibbin

As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision.

When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of each patient.

Patients should have the confidence to make decisions about their care in partnership with their doctor, without the fear that insurance companies or pharmacies will override those choices for non-medical reasons such as increasing profitability.

Unfortunately, a proposed policy change threatens to undermine this relationship and could disrupt the treatment stability of patients across Pennsylvania.

Biologic medications are commonly prescribed to treat conditions like cancer, arthritis and Crohn’s disease — serious chronic conditions that require careful management. “Biosimilars,” which are designed to mimic these biologic medications, help create competition and lower costs.

While these drugs are safe and effective, they are not exact copies of the original biologics. Because of this, insurers or pharmacies can’t simply switch my patients to a biosimilar without my approval, unlike with generic drugs.

However, the FDA does allow some biosimilars to be designated as “interchangeable,” meaning that a pharmacist could substitute the biosimilar for the original biologic without needing approval from the prescribing doctor.

To receive this designation, manufacturers must submit additional data, which sometimes includes patient studies to prove that safety and effectiveness remain the same — even if a patient is switched between the original and biosimilar multiple times.

While nearly 9 in 10 physicians trust the safety of biosimilars, the majority (69%) believe that the decision of which medication to use should be made by patients and their doctors — not insurers or pharmacies.

This is because treatment is never one-size-fits-all. Many of my patients have had to try several medications before finding the one that best stabilizes their condition. Unnecessary or inappropriate switching risks disrupting this hard-earned stability.

That’s why 59% of doctors are more comfortable with biosimilar substitutions when the FDA designates them as interchangeable — it assures us that the switch won’t compromise our patients’ health.

Congress, including Pennsylvania Sen. Bob Casey, is considering whether or not to remove these important safeguards.

The Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable, allowing insurance companies to switch patients to any biosimilar without prior physician approval — even if it hasn’t been demonstrated to the FDA that such switching won’t jeopardize treatment stability.

The bill would also effectively strip the FDA of its ability to request studies on switching, weakening the standards that currently protect patients.

It’s no surprise that doctors across the country overwhelmingly oppose these changes. A recent survey of 270 U.S. physicians who prescribe biologics showed that only 11% support classifying all biosimilars as interchangeable, and 88% believe that switching studies increase their confidence of safely switching their patients to biosimilars.

As physicians, our primary concern is our patients’ health and safety.

It is Congress’s responsibility to maintain the rigorous standards for biosimilar interchangeability that have protected patients, earned doctors’ trust, and saved our healthcare system $24 billion.

Failing to do so would put patient health at risk and erode physician confidence in these vital treatments.

Dr. Ralph McKibbin, MD, FACP, FACG, AGAF, is the chairman of the Alliance for Safe Biologic Medicines, and a Pennsylvania-based gastroenterologist. He serves as Clinical Assistant Professor of Gastroenterology at Duquesne University College of Osteopathic Medicine; and Director at Pennsylvania Society of Gastroenterology.

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

September 27, 2024

Prioritize Patient Treatment Stability, Physician Confidence

Michael Reilly
September 25, 2024

Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. To date, 59 biosimilars have been approved and have saved our health system $24 billion. The FDA’s approval standards have rightly earned physician and patient trust. Unfortunately, Congress is now considering weakening those standards – which could inadvertently jeopardize the health of millions of patients and with it, confidence in these medicines.

While safe and effective, biosimilars aren’t generics because they aren’t identical copies of a biologic. Insurance companies and pharmacy benefit managers (PBMs) cannot treat biosimilars like generics and simply switch a patient to their preferred version, usually the more profitable medication. Under state law in all 50 states, only “interchangeable” biosimilars may be substituted by a third-party without prescriber approval. Interchangeables have demonstrated to the FDA through data, including switching studies, that a patient can expect the same results with no additional risks, even after multiple switches, compared to a patient who remained on the original biologic.

Surveys show nearly all physicians – 89% – are confident in biosimilars. Nevertheless, 69% believe that patients and physicians should control the decision to switch medications, not insurers and pharmacists. That’s because treatment plans aren’t universal; they are as individual as patients themselves. Patients often try several different medicines before finding the one that works best to treat their condition. An interchangeable designation makes almost 60% of physicians more comfortable with a biosimilar substitution at the pharmacy, knowing a stable patient won’t be put at risk by third party-switching.

State medical societies nationwide support the laws now permitting the substitution of interchangeable biosimilars. However, that support was conditional on assurances from policymakers that third-party substitution would be limited only to interchangeable biosimilars backed by additional safety and efficacy data.

But the safeguards physicians count on may soon be removed. This week, the Senate HELP Committee, which includes my own senator, Tim Kaine of Virginia, will vote on a bill that would classify all biosimilars as interchangeable. It would permit insurance companies to switch patients to any biosimilar as if they were generics, removing prior physician approval, in absence of now-required data demonstrating that switching won’t reduce safety and efficacy. The Biosimilar Red Tape Elimination Act would also remove the FDA’s ability to ask for switching studies when appropriate, dangerously lowering current safety standards. If this bill becomes law, it could negatively impact treatment stability for millions of patients.

Both policies are strongly opposed by the clinicians who best understand these medicines. A recent survey of 270 physicians who prescribe biologics revealed that a mere 11% believe all biosimilars should be classified as interchangeable, and 88% said biosimilar switching studies increase their confidence in safe switching.

Congress has a responsibility to retain the rigorous standards for interchangeability that have kept U.S. patients safe, earned the trust of physicians, and lowered health care costs. A failure to do so will put patient health outcomes, and physician trust in these important medicines, in jeopardy.

Michael Reilly served in the Office of the Secretary of the U.S. Department of Health and Human Services from 2002-2008, including three years as Associate Deputy Secretary. He serves as Executive Director of the Alliance for Biologic Medicines and resides in Alexandria, VA.

Read the oped at RealClearHealth

Fact Sheet: Physicians Oppose S.2305 -That Would Make All Biosimilars Interchangeable

August 27, 2024

In August, ASBM released an updated fact sheet on Senate Bill S. 2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Mike Lee (R-UT), shoing how physicians overwhelmingly oppose its provisions. view it here: https://safebiologics.org/wp-content/uploads/2024/09/IC-RedTape-1p-FNL2.pdf

From the Fact Sheet:

U.S. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% also say the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. That’s because treatment plans aren’t one-size-fits-all. Each is uniquely tailored, and patients frequently try several products before finding one that best stabilizes their condition. Physicians need to be confident that a substitution by a pharmacy or insurance company won’t disrupt the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance, making a majority (59%) of U.S. physicians more comfortable with a pharmacy-level substitution.

From 2013-2021 all 50 state legislatures passed laws restricting automatic pharmacy substitution of biosimilars ONLY to interchangeable biosimilars. These laws were passed with the support of state medical
societies and patient organizations, conditional on these limits.

S.2305 would classify ALL biosimilars as interchangeable-inappropriately
permitting generic-style pharmacy substitution by insurance companies and pharmacy benefit managers, without the safety and efficacy data now needed. This would jeopardize treatment stability for millions of patients and betray the assurances made to physicians and patients nationwide that only biosimilars which had provided additional safety and efficacy data would ever be substituted without physician approval.

It would also restrict what data FDA can ask for to approve an interchangeable biosimilar, requiring the HHS Secretary to hold a private briefing with the chairs and ranking members of the Senate HELP and House Energy and Commerce Committees to justify asking for a study demonstrating switching won’t reduce safety or efficacy in patients.

Read the full Fact Sheet here.

S2305BSRedTape Download