Safe Biologics

On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy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

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.


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

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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