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/

Register for the December 12th ASBM/GCCA 340B Webinar!

December 11, 2025

Fact Sheet: Stop the “Genericization” of Biosimilars

November 5, 2025

The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?

StopGenericization-FNLREV Download

ASBM Submits Comments Urging FDA to Maintain Stringent Approval Standards, Opposing “Genericization” of Biosimilars

October 21, 2025

On October 19th, ASBM submitted detailed comments to the U.S. Food and Drug Administration regarding its September 19 public workshop, Advancing the Development of Interchangeable Products: Identifying Future Needs (Docket No. FDA-2025-N-2787).

ASBM expressed strong concern over signals that FDA may move toward “genericizing” biosimilars—modeling their approval and substitution on small-molecule generics—calling such a shift “scientifically inappropriate and potentially harmful to patient confidence.”

“Biosimilars are not generics,” ASBM wrote, “and leading regulators including FDA and EMA have consistently affirmed this indisputable scientific fact.”

The group emphasized that interchangeability decisions must continue to be based on rigorous, case-by-case scientific evaluation that considers real-world factors such as delivery mechanisms, user-interface differences, and patient variability.

“Calling a tiger a cat doesn’t make it a good house pet,” the submission warned, adding that a “cavalier attitude toward patient safety and treatment stability risks undermining hard-won physician and patient confidence.”

ASBM’s position reflects strong alignment with prescribers themselves. In its 2024 national physician survey, 88% of U.S. physicians supported FDA’s current case-by-case review for interchangeables, while only 11% favored treating all biosimilars as interchangeable by default. Nearly nine in ten physicians (87%) said they prefer switching only when a biosimilar has been rigorously evaluated for its switch impact, and 76% of European physicians likewise oppose substitution by anyone other than the prescribing doctor. These data underscore that the medical community values a cautious, evidence-based approach to interchangeability rather than automatic substitution modeled on generic drugs.

ASBM also highlighted that the true barriers to biosimilar uptake stem from pharmacy benefit manager (PBM) formulary design and rebate practices—not from FDA’s scientific standards—and urged the agency to maintain its current evidence-based framework:

“Lowering approval requirements or declaring all biosimilars interchangeable by fiat would not improve access; it would only erode confidence, destabilize treatment, and jeopardize the integrity of the U.S. biosimilars framework.”

Finally, ASBM called on FDA to include patient and clinician representatives at future workshops to ensure all stakeholder perspectives are represented.

Read the full comments here.

A Step Backward for Medication Safety and Confidence: FDA’s New Biosimilar Plan Revives Biden-Era “Genericization” Policy

October 1, 2025

October 31, 2025

ASBM: Biosimilars are not generics—so why is FDA pretending they are? Learn more: ASBM Fact Sheet- Stop the “Genericization” of Biosimilars

WASHINGTON, D.C. — The Alliance for Safe Biologic Medicines (ASBM) today expressed strong opposition to the Department of Health and Human Services’ continuation of a Biden-era regulatory initiative that inaccurately portrays biosimilars as “generic versions” of biologic medicines and seeks to eliminate key clinical data requirements that demonstrate biosimilar safety and performance.

“Biosimilars are safe, effective, and affordable alternatives—but they are NOT generics,” said Cristina V. Beato, MD, ASBM Board Member and former Assistant HHS Secretary. “Decades of regulation and law—both in the U.S. and abroad—recognize this indisputable scientific fact. Weakening the data requirements that verify comparable clinical performance would undermine patient and physician confidence at the very moment this Administration claims it wants to restore it.”

The FDA’s own educational materials affirm that “biosimilars are not generics—and important differences exist between them.” Across the world, every competent regulatory authority draws this same distinction:

The World Health Organization: “the generic approach is not suitable for the licensing of biosimilars.”
The European Medicines Agency: “a biosimilar is not regarded as a generic of a biological medicine.”
Health Canada: “unlike generic drugs, biosimilars can never be identical to their reference biologic drug.”
Australia’s Therapeutic Goods Administration: “a biosimilar is not a generic biological medicine.”
Japan’sPharmaceuticals and Medical Devices Agency: “the approach used for generic chemical drugs is not applicable because the active ingredient of a biosimilar…cannot be completely identical to that of the reference product”
Brazil’s ANVISA: “a biosimilar is not an exact replica of the reference…and, hence, cannot be considered as generic.”

Unlike small-molecule drugs, biologics—including biosimilars—require a totality-of-evidence approach: analytical, pharmacologic, and clinical data all play essential roles in ensuring comparable safety and efficacy in patients. Yet the FDA’s new draft guidance claims that comparative clinical studies “often add little value.”

“Analytical testing tells us a lot about the molecule,” said Ralph McKibbin, MD, ASBM Chairman. “But it can’t tell us how that medicine will behave in a patient or account for differences in product delivery devices. Clinical trials can—and do. Treatment plans aren’t one-size-fits-all. Clinical confirmation is what gives prescribers confidence that a biosimilar will work just as well in their patient.”

By resurrecting an ill-conceived Biden-era framework that conflates biosimilars with generics, weakens scientific standards, and elevates political expedience over patient safety, current FDA leadership is taking a step backward—inconsistent with the Administration’s stated goals of gathering more clinical data, ensuring greater transparency, and increasing public confidence in FDA-approved products.

ASBM urges FDA to reverse course and restore a data-driven biosimilar pathway built on science, transparency, and trust.

ASBM will submit detailed comments to the FDA within 60 days.

Media Contact: Michael Reilly
media@safebiologics.org

ASBM Announces Retirement of Doug Badger,Welcomes Beato and Downing to Board

July 7, 2025

ARLINGTON, VA — July 7, 2025 — The Alliance for Safe Biologic Medicines (ASBM) today announced the retirement of longtime Board member Doug Badger, and the appointment of two new members to its Board of Directors: Cristina V. Beato, MD, and Chris Downing, both of whom previously served in senior leadership roles at the U.S. Department of Health and Services (HHS) from 2001 to 2008.

Doug Badger retires after more than a decade of service as ASBM Board President. Prior to joining the ASBM Board, Badger had a widely respected career in health policy. He served as Special Assistant to the President for Economic Policy, Deputy Assistant to the President for Legislative Affairs, and Chief of Staff at the Senate Republican Policy Committee. Badger was instrumental in the development and implementation of the Medicare Modernization Act of 2003 leading to the creation of a prescription drug benefit for millions of seniors.

“Doug’s contributions to health policy in Washington have been immeasurable,” said Reilly. “It was a privilege to work alongside him—both in government and at ASBM. Few people can look back on their tenure in government and say that they have been personally responsible for improving the lives of millions of their fellow Americans. Doug not only improved their lives, but did so with humility.”

Dr. Cristina V. Beato is Associate Professor at the University of New Mexico School of Medicine and formerly served as Acting Assistant Secretary for Health at HHS, where she was the principal medical and scientific advisor to the Secretary. A Rear Admiral in the U.S. Public Health Service, she led federal initiatives on prevention, health equity, and public health preparedness. She also served as Chief Medical Officer at Ernst & Young, advising on global health strategy.

Chris Downing is President and CEO of the Georgia Health Care Association and brings more than 30 years of experience in public health, healthcare policy, and regulatory affairs. He held senior positions at CMS, CDC, FDA, and served in key policy roles on Capitol Hill. In the private sector, he directed federal government affairs for Enhabit Home Health & Hospice, Kindred Healthcare, and PruittHealth Corporation.

“Dr. Beato and Chris Downing bring deep expertise in public health and health policy,” said Reilly. “They have helped shape U.S. health policy from the highest levels of government and the private sector. Their insights will be invaluable as ASBM continues to advocate for policies that protect patients, empower healthcare providers, and ensure continued patient access to innovative, life-changing therapies.”

Media Contact: Ray Patnaude
media@safebiologics.org

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MFN: Medicines For No-One

June 3, 2025

What is MFN?—Why It’s a Threat to Patients

The Most Favored Nation (MFN) drug pricing policy ties U.S. medicine prices to those in countries with strict government price controls. This may sound like a win for patients, but MFN imports the very systems that limit access, delay innovation, and lead to higher death rates abroad—especially from diseases like cancer. In Europe, where these policies have long been in place, patients often wait months or years to access new treatments, and many breakthrough therapies never arrive at all. If implemented in the U.S., MFN could mean fewer medicines, slower innovation, and hundreds of thousands of preventable deaths—every year.

America has the best access to new cancer treatments in the world. If we dismantle that, U.S. patients will be the first to feel it. But make no mistake—patients worldwide will suffer.

Because in the end, MFN doesn’t mean “Most Favored Nation.” It means: Medicines for No-one.

More MFN Resources:

Executive Order Announcing MFN Drug Pricing Policy
ASBM Statement Opposing MFN Drug Pricing
Global Colon Cancer Association Statement Opposing MFN Executive Order
Andrew Spiegel Op-Ed: “How President Trump’s Executive Order Will Put An End To Pharmaceutical Breakthroughs”
‘Most-Favored Nation’ Drug Pricing Has Three Significant Problems – April 14, 2025 – USC Schaeffer
How Trump’s New Drug Pricing EO Differs From Past Attempts – John Barkett & Julia Bonavitacola
Unpacking President Trump’s New Executive Order on “Most-Favored-Nation” Prescription Drug Pricing

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.

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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.

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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.

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