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 Commending Senator Jim Banks for Introducing the SAFE Drugs Act of 2025

February 17, 2026

Download PDF version here

February 16, 2026

The Alliance for Safe Biologic Medicines (ASBM) commends Senator Jim Banks (R-IN) for introducing the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE Drugs) Act of 2026 in the United States Senate. We also support the bipartisan companion bill (H.R. 6509), introduced in the House of Representatives by Congressman Rudy Yakym (R-IN-02) and Congressman André Carson (D-IN-07).

The SAFE Drugs Act upholds critical patient safety protections within the Federal Food, Drug, and Cosmetic Act and strengthens oversight of drug compounding practices that have increasingly stretched beyond their intended purpose. Pharmacy compounding plays an important and legitimate role in patient care when FDA-approved therapies are unavailable or patient-specific factors make an available version clinically unsuitable. However, recent years have seen the expansion of large-scale production and interstate distribution of compounded drugs that closely replicate commercially available, FDA-approved products, but often do so without the rigorous FDA review and inspection standards that safeguard public health.

The SAFE Drugs Act addresses these concerns by clarifying the definition of “essentially a copy” of a commercially available drug product, establishing clear production thresholds, strengthening reporting requirements for interstate compounding, and enhancing inspection and oversight of large-scale compounding facilities. The legislation also modernizes FDA user fee authorities to ensure the agency has the resources necessary to conduct timely and effective inspections.

Founded in 2010, ASBM is a diverse group of stakeholders including physicians, pharmacists, patients, researchers, and manufacturers working together to advance patient-centered health policy in the U.S. and worldwide. ASBM supports reforms that preserve access to legitimate, patient-specific compounding while closing loopholes that allow the mass production of unapproved drugs outside the FDA approval framework. We believe the SAFE Drugs Act strikes this appropriate balance.

We thank Senator Banks for his leadership in advancing policies that protect patients, reinforce regulatory integrity, and uphold the high standards of the U.S. drug approval system.

Sincerely,

Ralph McKibbin, MD FACP FACG AGAF
Chairman, Alliance for Safe Biologic Medicines

Michael Reilly, Esq.
Executive Director, Alliance for Safe Biologic Medicines

Philip J Schneider MS FASHP FFIP
Advisory Board Chair, Alliance for Safe Biologic Medicines

ASBM Steering Committee Members:

Alliance for Patient Access
American Academy of Dermatology
Autoimmune Association
Association of Clinical Research Organizations
Colon Cancer Alliance
Global Colon Cancer Association
Global Healthy Living Foundation
Health HIV
International Cancer Advocacy Network
Kidney Cancer Association
Lupus and Allied Diseases Association, Inc.

National Hispanic Medical Association
National Psoriasis Foundation
ZeroCancer

ASBM Statement on FDA Commissioner’s Comments Regarding Compounded Medicines

February 6, 2026

The Alliance for Safe Biologic Medicines (ASBM) welcomes FDA Commissioner Marty Makary’s comments on the social media platform X affirming that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs” and warning that the agency will “take swift action against companies mass-marketing illegal copycat drugs.” These remarks accurately reflect ASBM’s longstanding concern regarding large-scale compounding pharmacies that copy FDA-approved medicines while sidestepping the FDA’s rigorous safety, quality, and oversight standards that protect patients.

While ASBM is encouraged by the Commissioner’s words, we remain concerned that insufficient action has been taken to date to rein in abuses by large-scale compounding pharmacies. We urge the FDA to follow these statements with strong enforcement actions that signal large-scale compounders cannot operate outside FDA oversight or scrutiny.

Philip Schneider, Chair of ASBM’s Advisory Board and a former president of the American Society of Health-System Pharmacists (ASHP), echoed Commissioner Makary’s concerns and praised the FDA for calling attention to the issue.

“Compounding pharmacies play a critical role in our medication delivery system – particularly during drug shortages or when patient-specific factors require a customized formulation. But when compounded drugs are mass-produced to copy FDA-approved therapies, they bypass standards for quality, consistency, and accountability that cannot be replicated outside the FDA approval process.”

Schneider and fellow ASBM advisory board member Ronald Jordan, past president of the American Pharmacists Association (APhA) and Dean Emeritus at the Chapman University College of Pharmacy have written extensively on the risks of inappropriate compounding and have conducted educational courses at colleges of pharmacy nationwide on the topic. Jordan highlights the importance of FDA oversight for compounded medicines:

“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.”

To support and educate policymakers, pharmacists, and the public on the issue, ASBM has launched SafeRxCompounding.org, a dedicated microsite that tracks the rapidly evolving compounding landscape. The site aggregates original analysis, expert commentary, news coverage, and peer-reviewed research, and provides links to relevant federal and state legislation addressing unsafe or unlawful compounding practices. More information is available at SafeRxCompounding.org.

ASBM Submits Comments on FDA Draft Guidance Reducing the Role of Comparative Efficacy Studies in Biosimilar Approvals

January 20, 2026

On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.

In the comments, ASBM supports FDA’s recognition that comparative analytical assessments (CAA) have become increasingly powerful and, in many cases, more sensitive than traditional comparative efficacy studies (CES) for detecting product differences. ASBM agrees that thoughtful, science-based streamlining – applied on a case-by-case basis – can be appropriate and consistent with a modern biosimilar development paradigm.

However, ASBM warns that reducing CES expectations cannot be viewed in isolation, particularly when paired with public messaging and policy initiatives that frame biosimilars as interchangeable generics. The comments emphasize that physician and patient confidence in biosimilars was built through a stepwise, totality-of-evidence framework integrating analytics, clinical pharmacology, immunogenicity, and targeted clinical data where appropriate – not analytics alone. From the comments:

“Alone, a science-based reduction in comparative efficacy study requirements may be reasonable in defined circumstances. In the current policy environment, however, CES reduction does not occur in isolation. It is unfolding alongside public statements by senior HHS and FDA leadership encouraging the public to ‘think of biosimilars as generics,’ proposals to eliminate the practical distinction between biosimilars and interchangeable biosimilars, and FDA support for legislative efforts such as the Biosimilar Red Tape Elimination Act. Together, these developments amount to a de facto ‘genericization’ of biosimilars that risks eroding physician and patient confidence in the U.S. biosimilar framework.”

ASBM urges FDA to clarify guardrails in the final guidance to avoid misinterpretation, reaffirm the continued role of clinical evidence where residual uncertainty exists, and clearly distinguish biosimilars from small-molecule generics. Preserving confidence, the comments argue, is essential to maintaining treatment stability, supporting responsible uptake, and realizing the savings biosimilars are intended to deliver.

Read ASBM’s comments here.

ASBM in GaBI Journal: “Biosimilars—Still Safe, Still Effective, Still Not Generics. Why Is FDA Pretending They Are?”

January 20, 2026

On January 12, the Brussels-based GaBI Journal published an editorial by ASBM Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Steering Committee member Andrew Spiegel examining an abrupt and troubling shift in U.S. biosimilars policy.

In the article, the authors argue that while biosimilars have consistently demonstrated safety and effectiveness, they are not – and cannot be -equated with small-molecule generics. Unlike generics, biologics are large, complex molecules that cannot be fully characterized by analytical testing alone. As the authors explain, even small differences in structure, formulation, delivery device, or conditions of use can have clinically meaningful effects—making a generic-style regulatory model scientifically inappropriate.

The central thesis of the article is that FDA’s recent efforts to “genericize” biosimilars risk eroding the scientific foundation of biologics regulation. By signaling reduced expectations for clinical evidence and encouraging broader automatic substitution, FDA departs from both the intent of the Biologics Price Competition and Innovation Act and the longstanding global consensus that biosimilars require a distinct, evidence-based framework. The authors warn that this shift could undermine physician and patient confidence, jeopardize informed decision-making, and ultimately weaken trust in biologic medicines.

The editorial contrasts FDA’s direction with the approaches of other major regulators—including the EMA, WHO, and Health Canada, which continue to emphasize the unique nature of biologics and the importance of tailored regulatory standards rather than a one-size-fits-all generic paradigm.

Read the full article here.

Experts Examine 340B Program, Reform Efforts in ASBM/GCCA Webinar

January 6, 2026

On December 12th, ASBM and the Global Colon Cancer Association (GCCA) hosted a one-hour webinar discussing the 340B Drug Discount Program, a federal program designed to help hospitals and clinics serving patients in need. The webinar, entitled “Reforming 340B: Ensuring the Discount Program Delivers for Patients” discussed how the program has strayed from its original mission- becoming a profit center for large, wealthy health systems. Presenters discussed the history and evolution of the program, highlighted current challenges, and examined bipartisan reform efforts underway in Congress to restore the program to its original mission.

Expert panelists included:

Thomas Barker; Former Deputy General Counsel, US Department of Health and Human Services
Madelaine Feldman, MD FACR; VP of Advocacy and Government Affairs, Coalition of State Rheumatology Organizations (CSRO)
Kathy Oubre, CEO, Ponchartrain Cancer Center
Michael Reilly; ASBM Executive Director, former Associate Deputy Secretary of the U.S. Dept. of Health and Human Services
Andrew Spiegel; Executive Director of the Global Colon Cancer Association

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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