Safe Biologics

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

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.

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.

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.

Reforming 340B: Ensuring the Discount Program Delivers for Patients December 12, 2025 • 11:00 AM – 12:00 PM ET Hosted by the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) Register Now The 340B Drug Discount Program was created to help hospitals and clinics stretch limited resources to serve vulnerable patients. Yet over time, the program’s lack of transparency and accountability has raised serious questions. Are these savings actually reaching the patients the program was meant to help? Join us for a live panel discussion as we examine the evolution of 340B, its current challenges, and bipartisan proposals for reform that could restore its original mission. Featured Speakers: Thomas Barker Former Deputy General Counsel U.S. Department of Health and Human Services Madelaine Feldman, M.D., FACR Vice President, Advocacy and Government Affairs Coalition of State Rheumatology Organizations (CSRO) Kathy Oubre CEO, Ponchartrain Cancer Center Andrew Spiegel Executive Director Global Colon Cancer Association (GCCA) We look forward to seeing you there!

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.