Posts – Safe Biologics

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/

ASBM Statement on Executive Order Implementing MFN Pricing

May 15, 2025

Statement from the Alliance for Safe Biologic Medicines (ASBM) on the Administration’s Executive Order Implementing MFN Pricing

May 15, 2025

The Alliance for Safe Biologic Medicines (ASBM) opposes the Administration’s May 12, 2025 Executive Order establishing Most Favored Nation (MFN) pricing for prescription drugs.

This approach would import foreign price controls from countries where patients wait longer and have less access to the newest, most effective treatments. In nations where these policies are in place, patients face higher mortality rates from diseases like cancer and have fewer therapeutic options overall. For example:

Of new cancer medications, 90% are available to US patients within the first year of launch, whereas less than half of these are available to cancer patients in Germany, the UK, France, and Canada within the first year.
Many medicines are never available in these jurisdictions: Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in Australia, Japan and the UK.
Cancer death rates per 100,000 are 1.6 to 1.8 times higher in Europe than those in the US. In a country the size of the U.S., European cancer death rates would translate to an additional 400,000 dead from cancer each year.

“This misguided proposal jeopardizes American leadership in pharmaceutical innovation and patient access to cutting-edge medicine by importing European-style price controls,” says Andrew Spiegel, ASBM co-founder and Executive Director of the Global Colon Cancer Association: “Europeans come to the U.S. for quality care and access to the newest and best treatments- we don’t go there. American patients should not be asked to accept reduced access and worse outcomes because the government is chasing shortsighted savings.”

Rather than importing flawed systems that ration access to lifesaving medicines, policymakers should build on the success of market-based competition in the U.S. in lowering prices—including the growing adoption of safe, effective biosimilars leading to $36 billion in savings since their introduction while building high confidence among physicians and patients. In addition, the Administration’s recent support for reforming the rebating and formulary practices of Pharmacy Benefit Managers (PBMs), widely acknowledged as contributing to the high cost of medications, presents a more promising means of controlling drug costs without reducing patient access.

ASBM urges the Administration to work with patient advocacy organizations, physicians, and other stakeholders to pursue policies that maintain America’s leadership in biopharmaceutical development and ensure patients have continued access to those medicines, rather than undermining these through misguided pricing mandates.

###

Trust is Built on Data: Preserving the FDA’s Evidence-Based Approach to Interchangeable Biosimilars

May 8, 2025

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM)

In a recent CBS News interview, newly appointed FDA Commissioner Dr. Marty Makary called for more robust clinical evidence before recommending the latest COVID-19 booster shots. “There’s a void of data,” Dr. Makary said, underscoring a renewed focus on restoring public trust through a commitment to rigorous, evidence-based evaluation.

This same data-first mindset is needed in discussions around biosimilars, especially interchangeable biosimilars—the only biosimilars that can be substituted by third parties such as insurers or pharmacy benefit managers (PBMs) without physician involvement.

Any efforts to weaken or eliminate data requirements for biosimilars or interchangeable biosimilars jeopardize the hard-earned confidence physicians and patients have developed in these products. The FDA recently updated its guidance to allow sponsors to avoid providing supplemental data to support a claim of interchangeability in some cases. Because they are created by living cells, biologics cannot simply be copied and Congress appropriately created a separate regulatory framework, distinct from generic drugs. Any proposal to deem all biosimilars interchangeable- removing the additional data requirements that give interchangeable biosimilars their credibility and clinician trust is a back door to deeming biosimilars generic drugs.

This is a dangerous direction for patients concerned about maintaining treatment stability- and it’s not supported by U.S. physicians.

At an April 8th House Health Subcommittee hearing on biosimilars, Dr. Edward Edgerton, a practicing rheumatologist with the American College of Rheumatology (ACR), emphasized the importance of the current FDA standard to physician confidence:

“ACR strongly supports the rigorous pathway for interchangeability approved by the FDA in 2019. The FDA must ensure that biosimilars and interchangeable biosimilars are safe and effective. The ACR recognizes increasing cost pressures may cause payers to push patients toward biosimilars. This is most appropriate when there is data available.”

At the same hearing, Dr. Aaron Kesselheim, a Harvard Medical School professor affirmed that trust in biosimilars cannot be assumed, and that clinical studies play a role:

“Because these are very large, complex molecules—unlike small molecules—those small differences can really make big impacts on the efficacy and safety of these drugs. And while for some biologics we know those small differences are safe, for others we might not. That’s why the role of the FDA in determining when we can safely approve biosimilars, and when more testing is needed, is critically important. We cannot undermine the essential work the FDA does in guiding companies through this process.”

This sentiment is echoed by biosimilar manufacturers themselves. In a recent press release, Celltrion stated:

“Interchangeable designation provides confidence among patients and healthcare providers… [it] is a key differentiator that offers greater assurance.”
Celltrion FDA approval announcement

And these assertions are also borne out by available data. ASBM’s multi-specialty surveys of U.S. biologic prescribers revealed that:

85% of U.S. physicians support the current FDA standards for approving interchangeable biosimilars
89% say switching studies are important before allowing automatic substitution
Only 11% support treating all biosimilars as interchangeable.

According to the Biosimilars Council, biosimilars have saved $36 billion since their introduction—a clear indication that the current framework is working. As policymakers look to the future, the goal should be to build on this success. Undermining standards may offer short-term gains for middlemen like insurers and PBMs, but risks long-term damage to patient trust and physician confidence.

Statement from the ASBM on Senate HELP Committee 340B Reform Report

April 29, 2025

The Alliance for Safe Biologic Medicines (ASBM) commends Senator Bill Cassidy and the Senate HELP Committee for their new report, “Congress Must Act to Bring Needed Reforms to the 340B Program.” The program is designed to support underserved populations by ensuring access to medicines by allowing qualifying entities to safety-net hospitals, community health centers, and federally qualified health centers (FQHCs) to purchase outpatient drugs at discounted prices and reinvest the savings into expanded care for vulnerable patients. However, over time, the program has deviated from this original mission, often becoming a source of profit for large health systems, contract pharmacies, and third-party administrators instead of vulnerable patients.

Senate HELP Committee investigations have revealed that some large hospital systems, such as Bon Secours Mercy Health and Cleveland Clinic, have generated hundreds of millions of dollars in 340B revenue and used these to fund capital improvements rather than passing these discounts directly to patients. Contract pharmacy arrangements and associated fees have also diverted 340B savings away from patients.

Michael Reilly, Executive Director of ASBM and former Associate Deputy Secretary of the U.S. Department of Health and Human Services (HHS), emphasized the importance of these reforms, stating:

“The 340B program’s original mission was noble: to expand access to care for vulnerable patient populations. Senator Cassidy’s reforms are long overdue and will help ensure that 340B savings are used as intended — improving patient care, not enriching middlemen”

The Report’s proposed reforms include:

Transparency in 340B Revenue Use: Mandates hospitals and clinics to report how savings are spent, ensuring funds are used to lower patient costs or expand services.
Clear Patient Eligibility Standards: Establishes a precise definition of a “340B patient,” ensuring discounts are tied to care for truly underserved populations.
Regulation of Contract Pharmacy Fees: Investigates and curbs excessive fees by pharmacies and third-party administrators, allowing more savings to benefit patients.
Strengthen Oversight: Helps prevent duplicate discounts and diversion, ensuring the 340B program remains sustainable for both manufacturers and patients.
Stronger Enforcement Authority for HRSA: Empowers the Health Resources and Services Administration to oversee compliance and penalize abuse effectively.

ASBM urges Congress to swiftly enact these reforms to restore transparency and accountability and help refocus the 340B program on its core mission: ensuring vulnerable patients can access the medicines they need.

###

ASBM Statement on President Trump’s Executive Order Supporting Patients Who Depend on Small-Molecule Medicines

April 21, 2025

The Alliance for Safe Biologic Medicines (ASBM) commends President Donald J. Trump for his leadership in issuing an executive order to address the harmful “pill penalty” contained within the Inflation Reduction Act (IRA). This provision, enacted during the Biden administration, imposes price controls on small-molecule medicines—commonly delivered in pill or tablet form—just nine years after FDA approval, while granting biological medicines a longer 13-year timeline for manufacturers to recoup their research and development cost.

This disparity disincentivizes investment in the medicines which treat many widespread and serious conditions, including cancer, heart disease, diabetes, and hypertension. Small-molecule drugs account for over 90% of all prescriptions filled in the United States. Yet under the IRA, they are subjected to more aggressive price controls simply because of how they are manufactured. An analysis by the University of Chicago projected the IRA’s pill penalty would lead to the loss of 188 small-molecule therapies and an estimated 116 million life-years.

Research has shown this shift is already underway– investment in small-molecule drug development has plummeted 68% since the IRA’s passage—and by 74% for therapies aimed at Medicare-aged patients.

By directing the Department of Health and Human Services to work with Congress to restore parity between small-molecule and biologic drugs under the Medicare Drug Price Negotiation Program, President Trump is standing with American patients and protecting American innovation. His executive order, together with the bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act, which eliminates the pill penalty legislatively, offers a critical course correction to protect access to essential medicines for all patients, regardless of how those treatments are delivered.

“Patients battling cancer and other serious illnesses depend on timely access to effective treatments,” said ASBM Executive Director Michael Reilly. “The ‘pill penalty’ has inadvertently discouraged the development of small-molecule drugs that are often the only way to treat certain cancers. President Trump’s executive order is a pivotal step toward restoring balance and prioritizing patient needs in our healthcare system.”

ASBM urges Congress to build on this leadership by swiftly advancing the EPIC Act and ensuring that lifesaving innovation is supported across all classes of medicine—for the benefit of current and future patients alike.

###

Debunking Misinformation on Interchangeable Biosimilars

March 20, 2025

A recent IQVIA report funded by the generics industry trade group Association for Accessible Medicines is propagating several misleading claims about interchangeable biosimilars. ASBM has frequently addressed misinformation efforts about interchangeablity biosimilars in recent months, to correct the record and reinforce the rigorous FDA standards now protecting patient safety and treatment stability. Here are some of the false and misleading claims from the report alongside factual corrections:

False Claim: The report suggests U.S. physicians are hesitant to prescribe biosimilars due to negative perceptions of their quality. Fact: Surveys show that 92% of U.S. physicians trust the safety and efficacy of biosimilars, with 89% willing to prescribe them. The primary concern is who controls substitution: 69% support physician/patient control; 58% oppose insurer/PBM-driven switching.
Misleading Claim: It misleadingly states that the European Medicines Agency (EMA) declared all biosimilars interchangeable with their reference products. Fact: The EMA’s designation of interchangeability explicitly refers to prescriber substitution, not pharmacy switching, which is often banned in Europe.
False Claim: The report falsely claims that biosimilar developers must conduct switching studies to achieve FDA interchangeable status. Fact: The FDA has approved the majority of interchangeable biosimilars without requiring clinical switching studies, but has discretion about what type of data it may require. Notably, 88% of U.S. physicians affirm that such studies increase their confidence in these medications [Source].
Misleading Claim: It argues that state-level policies on interchangeability introduce complexities to the market. Fact: There is a broad agreement on policy: every U.S. state allows any biosimilar to be prescribed by physicians, but only FDA-designated interchangeables can be substituted by third parties like insurers and PBMs. Only 11% of physicians support permitting third-party substitution of all biosimilars.
Misleading Claim: The report suggests that the interchangeability designation implies non-interchangeable biosimilars are inferior. Fact: 92% of U.S. physicians trust the safety & efficacy of biosimilars. The issue isn’t perception—it’s treatment stability. Interchangeable biosimilars provide data proving that switching won’t compromise outcomes. 87% of physicians prefer switching patients only if the biosimilar has been rigorously evaluated for its impact on safety & efficacy.
Misleading Claim: It posits that “confusion around interchangeability” hampers biosimilar development. Fact: There is an overwhelming consensus among all U.S. States and DC about biosimilars: any biosimilar may be prescribed by physicians, but only FDA-designated interchangeable biosimilars may be substituted by third parties (insurers, PBMs). Their extra data ensures switching won’t compromise safety/efficacy. Again, only 11% of physicians support permitting third-party substitution of all biosimilars.

For more detailed discussions and to dispel common myths about interchangeable biosimilars, refer to the ASBM’s Myth vs. Fact Sheet or visit www.SafeBiologics/ICBiosims.

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

ASBM Praises Introduction of the EPIC Act

March 7, 2025

FOR IMMEDIATE RELEASE

March 7, 2025

Arlington, VA – The Alliance for Safe Biologic Medicines (ASBM) today expressed its support and gratitude to Senators Thom Tillis (R-NC), Ted Budd (R-NC), Marsha Blackburn (R-TN), James Lankford (R-OK), and Steve Daines (R-MT) for their leadership in introducing the Ensuring Pathways to Innovative Cures (EPIC) Act (S. 832) March 4^th. This vital legislation aims to maintain America’s global leadership in pharmaceutical innovation and ensure continued access to essential drugs for patients.

Under the Inflation Reduction Act (IRA), small-molecule drugs, which account for more than 90% of all prescriptions and typically come in pill form, are subjected to price control mechanisms just nine years after their market introduction. In contrast, biologic medicines—complex treatments administered via injections or infusions—are not subjected to price negotiations until 13 years post-launch. This disparity discourages investment in small-molecule drug research, as manufacturers have a shorter period to recoup their research and development costs. Since the implementation of the IRA in 2021, investment in small-molecule drug development has plummeted by 70% as manufacturers shift resources toward biologics.

“The ‘pill penalty’ imposed by the IRA has severely curtailed investment in small-molecule drug research,” stated Michael Reilly, Executive Director of ASBM and former Associate Deputy Secretary in the U.S. Department of Health and Human Services. “Small molecule drugs are critical for the treatment of many serious conditions like heart disease, cancer, and mental health disorders. This ‘pill penalty’ jeopardizes the health of millions of patients today and in the future as new small molecule treatments aren’t developed. The EPIC Act is a crucial step in ensuring that American patients continue to have access to innovative therapies for these and other conditions.”

The EPIC Act aims to address these disparities by establishing a level playing field for small-molecule drugs and biologic medicines, which is essential for fostering the continued development of all types of drugs. “We commend the senators for their vision and commitment to securing a healthier future for all Americans,” added Reilly.

The Alliance for Safe Biologic Medicines urges members of both chambers of Congress to support the EPIC Act and its companion bill in the House of Representatives (H.R. 1492). This legislation promise to safeguard innovation and ensure ongoing investment in medical advancements that benefit patients nationwide.

To learn more about the importance of this legislation and the broader impact of the IRA’s policies, please visit our website: www.SafeBiologics.org/IRA

MEDIA INQUIRIES:
media@SafeBiologics.org

About ASBM
The Alliance for Safe Biologic Medicines (ASBM) is a diverse coalition of stakeholders, including physicians, pharmacists, patient advocates, researchers, and biopharmaceutical manufacturers. Since 2010, ASBM has worked with regulators worldwide to shape policies that reflect the best interests of patients, ensuring access to lifesaving and life-enhancing medicines while fostering innovation in healthcare.

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

ASBM Statement on FDA Announcing End of 2-Year GLP-1 Shortage

March 5, 2025

On February 22nd, the US Food and Drug Administration (FDA) announced the resulution of a years-long shortage of semaglutide, the key ingredient in popular GLP-1 weight loss and diabetes medications Ozempic amd Wegovy. Both drugs have been on the FDA’s drug shortage list since 2022. During the shortage, compounding pharmacies were permitted to increase patient access to these medications by compounding their own version. But with the shortage over, this is no longer the case. In a statement, ASBM highlighted the need for education around the role played by compounding pharmacies during a shortage, including the lower manufacturing and safety standards to which they are held. From ASBM’s statement on the announcement:

“Compounding pharmacies provide an important public service by increasing supply of medicines that are in shortage,” says Philip Schneider, Chair of ASBM’s Advisory Board and past president of the American Society of Health-system Pharmacists (ASHP). “But some compounding pharmacies are now trying to continue this practice after a drug shortage ends—skirting FDA safety regulations and oversight, and potentially jeopardizing patient health.” Compounding pharmacies’ lower regulatory compliance costs can contribute to a lower price point, which is frequently emphasized in direct-to-consumer advertising such as a recent Super Bowl ad for compounded GLP-1s watched by 123 million people.

Ronald Jordan, former president of the American Pharmacists Association (APhA) and a member of ASBM’s Advisory Board, highlights the need for more education on the risks of pharmacy compounding: “The U.S. drug supply is probably the safest in the world because of the FDA’s standards for drug manufacturing—but the public should know that these standards don’t apply to compounders, and those that do are not consistently enforced. On a continuum of risk, U.S. drug manufacturers would be on the low end for risk and pharmacy compounders would be on the high end.”

Read the full statement here.

ASBM Urges Congress to Support EPIC Act: Remove IRA’s “Pill Penalty” to Ensure Continued R&D for Small-Molecule Drugs

March 5, 2025

On February 25th, the House of Representatives introduced the Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) an important step toward fixing the Inflation Reduction Act’s (IRA) small molecule pill penalty. Small-molecule drugs typically come in pill or tablet form, and comprise 90% of prescriptions filled in the U.S. The Senate introduced its companion bill, S. 832, on March 4th. In response, ASBM released a statement urging legislators in both chambers to support the EPIC Act.

Read ASBM’s statement supporting the EPIC Act here.

View a Fact Sheet on the “Pill Penalty” developed by ASBM Member We Work For Health here.

Learn more about how the IRA affects patients at ASBM’s microsite IRAPatientInfo.org

——