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.

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. From ASBM’s statement:

“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.”

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

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ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

February 27, 2025

On February 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR joined Members of Congress and other high-profile supporters of PBM reform at a Congressional event urging leadership to include critical bipartisan PBM reform legislation in the anticipated March funding package.

The event, titled “Finish the Job! Pass PBM Reform Now” included welcome remarks from Rep. Buddy Carter (R-GA); Rep. Jake Auchincloss (D-MA); Rep. James Comer (R-KY). Among the bipartisan policy prescriptions the congressional leaders support:

Delinking the price of medicines from PBM profits
Rebate pass-through
Fair pharmacy contract terms in Medicare Part D
NADAC-based reimbursements in Medicaid managed care

These measures are essential to lowering drug costs and improving access for patients and must be prioritized in the final package.

Learn more about PBM Reform efforts here.

ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA

February 25, 2025

On February 20th, Philip Schneider, ASBM Advisory Board Chair, taught a 2-hour class at the Ohio State University College of Pharmacy that examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry.

The module examined 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 were 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.

November-December 2024

February 5, 2025

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.

ASBM Responds to PBM Industry Endorsement of Biosimilar Red Tape Elimination Act On December 9th, ASBM released a statement in response to the recent call by the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers (PBMs), that urged passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035). ASBM has consistently opposed the bill, which would eliminate the FDA standards biosimilars must currently meet in order for third-parties like PBMs to substitute them at the pharmacy level. This change would lead to widespread third-party substitution of all biosimilars, jeopardizing treatment stability for millions of patients and undermining physician confidence in biosimilar substitution. From the statement:The Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.Read the full statement here.

ASBM Exhibits at ACR Convergence 2024 During November, ASBM was proud to again participate in the American College of Rheumatology (ACR) Convergence 2024, held from November 14-19 in Washington, DC. ACR Convergence is known as the world’s premier annual rheumatology gathering. ASBM exhibited in the conference’s patient pavilion from November 15-18, and was represented at the meeting by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude. ASBM’s booth featured a variety of materials ASBM has developed over the past year on issues including interchangeable biosimilars and the Inflation Reduction Act; as well as a monitor playing recent ASBM webinars on these and other topics. Joining ASBM as exhibitors were ASBM member organizations including the Lupus and Allied Diseases Association (LADA) and Ai Arthritis. Read more about ACR Convergence 2024 here.

FDA Approves 63rd Biosimilar, Its 17th in 2024 In December, 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 17. Read about the approval here.
View all approved FDA biosimilars here.

ASBM Resource Recap: Biosimilar Red Tape Elimination Act As a part of ASBM’s ongoing educational efforts surrounding S.2035, the Biosimilar Red Tape Elimination Act, we have recently released several resources for policymakers and the general public. These include:A Myth vs. Fact sheet which highlights several serious factual errors and misinformation used in efforts to promote and gain support for the bill. Op-ed from ASBM Executive Director Michael Reilly (RealClearHealth)Op-ed from ASBM Chairman Ralph McKibbin MD (Altoona Mirror)An October 31st Webinar ASBM/Generics and Biosimilar Initiative For more ASBM educational materials on the Biosimilar Red Tape Elimination Act click 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 Responds to PCMA: Put Patients First, Not PBM Profits

December 12, 2024

Press Release

ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.

The bill would automatically declare all biosimilars as “interchangeable” with their reference biologics. Currently, manufacturers must demonstrate to the FDA that switching between their biosimilar and the reference biologic will not reduce safety or efficacy, jeopardizing patients’ treatment stability. If enacted, the bill would also overrule laws in all 50 states limiting pharmacy substitution to interchangeables. The state laws were widely supported by state medical societies and patient advocacy organizations, their support conditioned on the reassurances provided by the scientific standards the pending legislation would eliminate.

“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”

Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.

When informed of the proposal, physicians overwhelmingly oppose it. A recent survey of 270 U.S. biologic prescribers revealed:

Only 11% support automatically classifying all biosimilars as interchangeable.
88% believe biosimilar switching studies increase their confidence in the safety of biosimilar substitutions.
69% agree that decisions about switching should remain between patients and their doctors, not insurers or pharmacies.

These findings underscore the widespread physician concern that the legislation undermines their ability to provide safe, personalized care. Indeed, 40 physician organizations recently sent a letter to Congress questioning the bill’s likelihood of increasing biosimilar access, and suggesting alternative ways to promote biosimilar uptake. The letter noted that “commercial plans including Medicare Advantage pay no attention to the interchangeability of a biosimilar when constructing formularies” [the list of covered medicines], they consider “only the size of rebates and fees collected.”

“Congress must prioritize patients over profits by retaining the rigorous standards that have earned physician trust and protected patients for nearly a decade,” said Reilly. “If policymakers truly want to promote biosimilar uptake, they should explore alternate pathways – ones that don’t erode safety standards, undermine physician confidence or risk destabilizing patient treatment plans.”

Media Contact:
Michael Reilly
media@safebiologics.org
(202) 222-8326

September-October 2024

November 14, 2024

SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st

On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S. biosimilar approval and substitution policies, discuss the rationale behind them, and examine the potential consequences of the proposed changes. Healthcare practitioners and patient advocacy representatives will also share their concerns about the Biosimilar Red Tape Elimination Act’s effects on physican confidence in biosimilars and its potential to jeopardize treatment stability for patients nationwide.

More details and the program agenda will be made available soon.

Read more about physician concerns with S.2305 here.

Dr. McKibbin Op-ed: Lowering the Interchangeable Biosimilar Standard Endangers Patient Health On October 3rd, an op-ed by ASBM Chairman Ralph McKibbin MD ran in the Pennsylvania-based Altoona Mirror. In the article, Dr. McKibbin highlights physician concerns with Senate Bill 2035, the “Biosimilar Red Tape Elimination Act”, under consideration by the Senate Committee on Health, Education, Labor, and Pensions (Senate HELP). The U.S. physicians who prescribe biologic medicines, however, do not support the bill’s provisions, McKibbin explains: The Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable, allowing insurance companies to switch patients to any biosimilar without prior physician approval — even if it hasn’t been demonstrated to the FDA that such switching won’t jeopardize treatment stability.
The bill would also effectively strip the FDA of its ability to request studies on switching, weakening the standards that currently protect patients.
It’s no surprise that doctors across the country overwhelmingly oppose these changes. A recent survey of 270 U.S. physicians who prescribe biologics found that only 11% support classifying all biosimilars as interchangeable, and 88% believe that switching studies increase their confidence of safely switching their patients to biosimilars.
As physicians, our primary concern is our patients’ health and safety.It is Congress’s responsibility to maintain the rigorous standards for biosimilar interchangeability that have protected patients, earned doctors’ trust, and saved our healthcare system $24 billion.

Read the full op-ed here.

ASBM’s Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards On September 25th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly, discussing widespread physician opposition to key components of S.2305, “The Biosimilar Red Tape Elimination Act”, which would declare all biosimilars interchangeable and thus, substitutable at the pharmacy level by insurance companies and PBMs. State medical societies nationwide support the laws now permitting the substitution of interchangeable biosimilars. However, that support was conditional on assurances from policymakers that third-party substitution would be limited only to interchangeable biosimilars backed by additional safety and efficacy data.
But the safeguards physicians count on may soon be removed. This week, the Senate HELP Committee, which includes my own senator, Tim Kaine of Virginia, will vote on a bill that would classify all biosimilars as interchangeable. It would permit insurance companies to switch patients to any biosimilar as if they were generics, removing prior physician approval, in absence of now-required data demonstrating that switching won’t reduce safety and efficacy. The Biosimilar Red Tape Elimination Act would also remove the FDA’s ability to ask for switching studies when appropriate, dangerously lowering current safety standards. If this bill becomes law, it could negatively impact treatment stability for millions of patients. Reilly cited the findings of ASBM’s recent survey of 270 prescribers of biologic medicines. That survey revealed that only 11% support declaring all biosimilars interchangeable. 88% said switching studies increased their confidence in safe biosimilar substitution. The survey results come at a time when the interchangeable biosimilar standard faces several policy challenges. In August, ASBM shared the findings with the FDA as part of a public comment period on Draft Guidance that would de-emphasize switching studies. Read the full op-ed here. Read the U.S. physician survey here and the press release about its findings here. Read more about S.2305 here.

ASBM Chairman Discusses Interchangeable Biosimilar Policy at Washington, DC Policy Forums On September 23rd and 24th, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF visited Washington, DC to participate in two policy forums at which he shared physician perspectives on biosimilars policy. The first event was a 2024 Fall Policy Forum hosted on Capitol Hill by the Digestive Disease National Coalition (DDNC). The meeting was attended by Hill staff and key lawmakers who work on health policy. Attendees included Representatives Jim McGovern (D-MA) and Buddy Carter (R-GA). Representative Carter is a pharmacist and member of the House Energy & Commerce Committee’s Health Subcommittee. Dr. McKibbin used the meeting as an opportunity to share results of ASBM’s recent physician survey, showing strong opposition to S.2305, “The Biosimilar Red Tape Elimination Act” (see above articles) which would declare all biosimilars interchangeable and thus, substitutable at the pharmacy level by insurance companies and PBMs. The following day, Dr. McKibbin participated in a panel discussion entitled “the Changing Landscape of Biologics”, as part of the Alliance for Patient Access’ (AfPA’s) 9th Annual Policy & Advocacy Summit. McKibbin provided the physician perspective on a variety of topics including interchangeable biosimilar and substitution policy, non-medical switching, and the continued need for physician reimbursement and Pharmacy Benefit Manager (PBM) reforms. View Dr. McKibbin’s panel discussion here.

ASBM Letter to US Senate Details Overwhelming Physician Opposition to “Biosimilar Red Tape Elimination Act” On September 6, ASBM sent a letter to Senator Mike Lee (R-UT), sponsor of Senate Bill 2305 (S.2305), the “Biosimilar Red Tape Act”. The letter was also sent to cosponsors of the bill, including Sen. Mike Braun, (R-IN), Sen Ben Ray Lujan (D-NM), Sen. Rand Paul (R-KY), and Sen. JD Vance (R-OH). The letter details the opposition among U.S. physician opposition to key components of S. 2305. These include a provision that the FDA designate all biosimilars as interchangeable (and thus substitutable like generics- without physician involvement- at the pharmacy level by third parties such as insurance companies and pharmacy benefit managers (PBMs). The bill also removes the FDA’s authority to consider switching studies when making a determination that safety and efficacy do not diminish following a biosimilar substitution. From the letter: The letter shared survey data from ASBM’s August survey of 270 physicians, which showed strong opposition to key provisions of S.2305. For example, only 11% of physicians supported making all biosimilars interchangeable, as the bill would. In addition, 88% said that switching studies- showing no loss of efficacy or safety- increased their confidence in an interchangeable biosimilar being substituted. S. 2035, however, would remove the FDA’s ability to consider such studies during biosimilar approval. Read the letter to Sen. Lee and the bill’s cosponsors here. Read more about S. 2035 here. Read ASBM’s physician survey here and the press release about its findings here.

ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA On September 30, Philip Schneider, ASBM Advisory Board Chair, taught a 2-hour class at the University of Colorado-Boulder’s College of Pharmacy entitled “Biosimilar Medicines”. The course examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry. The module examined three current policy issues related to biosimilars:The likely negative impact of the Inflation Reduction Act’s price-setting on biosimilar development and commercialization;
Senate Bill 2035 (the 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 were given basic information about each proposal, and then asked to research further and discuss challenges each policy might pose to increasing patient access to safe and affordable therapies. In February 2025, Schneider will offer a version of the course at Ohio State University’s College of Pharmacy, where he is a professor of pharmacy. ASBM and the OSU College of Pharmacy recently collaborated on 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. The ACPE-accredited course is worth 7 hours of continuing education credit and is open to all pharmacists nationwide and may be accessed here.

ASBM and GaBI Present Webinar on the Biosimilar Red Tape Elimination Act

On October 31st, ASBM and the Generics and Biosimilar Initiative presented a webinar focusing Senate Bill 2305 (S.2305) the Biosimilar Red Tape Elimination Act. Currently, state laws nationwide permit only “interchangeable” biosimilars to be automatically substituted by insurers of pharmacy-benefit managers (PBMs), the way generics may be substituted- without physician approval. Whil safe and effective, unlike generics biosimilar are not identical to their reference products. To earn the interchangeable designation, manufacturers of these biosimilars must demonstrate to the FDA that switching a patient will not reduce safety or efficacy of treatment, through additional data that sometimes including switching studies. The bill would for the first time permit widespread and unrestricted pharmacy-level substitution of all biosimilars, inappropriate treating them as generics for substitution purposes.

During the webinar, ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider reviewed current U.S. biosimilar approval and substitution policies, discussed the rationale behind them, and examined the potential consequences of the proposed changes.
Reilly, who recently co-authored a whitepaper about how misinformation is distorting U.S. interchangeable biosimilar policy, highlighted multiple misconceptions underpinning the bill, performing a “fact check” on several inaccuracies in a press release announcing its introduction.
For example, the bill’s press release stated that biosimilars are equivalent to generics and that switching studies are required for approval as interchangeable. In reality, the FDA has said that “biosimilars are not generics and important difference exist between them” and that they “were able to approve the majority of interchangeable biosimilars without clinical switching studies.” In addition, the press release stated that the European Medicines Agency (EMA) determined that switching studies are not necessary for interchangeability, inaccurately suggesting that S.2305 would align the U.S. with European policy. In reality, the EMA has said its use of the term refers to substitution of biosimilars by the prescribing physician, not automatic pharmacy-level substitution of biosimilars, a practice banned in much of Western Europe and not within the remit of the EMA.
ASBM Chairman Ralph McKibbin MD shared concerns that physicians have with the Biosimilar Red Tape Elimination Act. A recent survey of 270 U.S. physicians revealed only 11% support all biosimilars being deemed interchangeable. ASBM Steering Committee Member Andrew Speigel, Executive Director of the Global Colon Cancer Association, shared patient concerns about the Bill. In particular, Spiegel stressed the potential of the unprecendented large-scale third-party substitution the bill would unleash to jeopardize treatment stability for patients nationwide.
More details and the program agenda will be made available soon.
View the webinar here.

ASBM Presents at 79th WHO INN Consultation
On October 22nd, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 79th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland.
ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO.
However, the Executive Summary from the 78th INN Consulation (held March 18, 2024 and at which ASBM also presented) lays out the benefits of a distinct global nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators:
The ASBM intends to defend the role of clinical data in biosimilar approval and this trend toward deemphasis of clinical data in biosimilar approval also makes strong post-marketing pharmacovigilance all the more important.
The benefits of a WHO led distinct nomenclature standard remain clear and would benefit the least economically-developed countries of the world. The meeting was reminded of previous ASBM studies that show strong support for distinct naming including regulators in large and small countries. Some regulators have adopted their own specific naming system and some who initially supported the BQ have initiated their own system would be happy to adopt a WHO global standard.
In summary, as the INN Group still supports its recommendation for distinct suffixes, as strong support for distinct naming remains amongst regulators and as lead regulators push for reduced emphasis on clinical trials in biosimilar approvals and stronger biologic pharmacovigilance becomes increasingly important, ASBM is determined to advance the proposal by working with the WHO and other National Regulatory Authorities worldwide.
Read the full Executive Summary of the 78th INN Consultation here.

Missed last month’s ASBM Newsletter?Read it here.

ASBM Presents at 79th WHO INN Consultation
On October 22nd, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 79th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland.
ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO.
However, the Executive Summary from the 78th INN Consulation (held March 18, 2024 and at which ASBM also presented) lays out the benefits of a distinct global nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators:
The ASBM intends to defend the role of clinical data in biosimilar approval and this trend toward deemphasis of clinical data in biosimilar approval also makes strong post-marketing pharmacovigilance all the more important.
The benefits of a WHO led distinct nomenclature standard remain clear and would benefit the least economically-developed countries of the world. The meeting was reminded of previous ASBM studies that show strong support for distinct naming including regulators in large and small countries. Some regulators have adopted their own specific naming system and some who initially supported the BQ have initiated their own system would be happy to adopt a WHO global standard.
In summary, as the INN Group still supports its recommendation for distinct suffixes, as strong support for distinct naming remains amongst regulators and as lead regulators push for reduced emphasis on clinical trials in biosimilar approvals and stronger biologic pharmacovigilance becomes increasingly important, ASBM is determined to advance the proposal by working with the WHO and other National Regulatory Authorities worldwide.
Read the full Executive Summary of the 78th INN Consultation here.

Myth vs Fact: The Biosimilar Red Tape Elimination Act

November 14, 2024

Click here to download the Myth vs Fact Onepager.

ASBM Physician Survey on Interchangeable Biosimilars Finds Support for Maintaining Current Standards

October 13, 2024

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

FOR IMMEDIATE RELEASE– September 4, 2024
Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic medicines they copy, according to a recent survey of 270 U.S. physicians. The August 2024 survey, conducted on behalf of the Alliance for Safe Biologic Medicines, documents the perspectives of specialists from nine practice areas in which biologic medicines are routinely prescribed, including gastroenterology, oncology, rheumatology, and others.

“All FDA-approved biosimilars are safe and effective, but treatment plans are not universal or “one-size-fits-all”, explains ASBM Chairman Ralph McKibbin, MD. “Each is uniquely tailored, and patients frequently try several products before finding one that best stabilizes their condition. Physicians need to be confident that a substitution by a pharmacy or insurance company won’t disrupt a patient’s hard-won treatment stability. The interchangeable standard’s rigorous data requirements, often including switching studies, provide that assurance.”

Key Findings from the Survey:

88% of physicians agree that switching studies increase their confidence in the safety of switching patients from an originator medicine to an interchangeable biosimilar
87% of physicians prefer switching patients to a biosimilar only if it has been rigorously evaluated for its impact on safety and efficacy when switched from an originator biologic.
88% believe an interchangeable biosimilar should undergo individual evaluations to determine the impacts of switching on patient safety and efficacy.
Only 11% of respondents are in favor of deeming all biosimilars as interchangeable without these evaluations.
85% agree that biosimilars should only be considered interchangeable if they have been specifically assessed for safety and efficacy in switching scenarios.

In the U.S. as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. But because biosimilars are not identical to their reference products, pharmacy substitution is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. Under U.S. state laws, only biosimilars deemed “interchangeable” by the FDA may be substituted at the pharmacy without physician involvement the way generic drugs are. “These laws were passed with the support of state medical societies nationwide, which was conditional on pharmacy substitution being limited only to interchangeable biosimilars”, notes ASBM Executive Director Michael Reilly.

The survey’s results are consistent with prior surveys, says Reilly: “A 2021 survey revealed that while 89% of U.S. physicians are confident in the safety and efficacy of biosimilars; 69% believe only the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. But the majority (59%) are more comfortable with a pharmacy-level substitution of an interchangeable because of the additional safety and efficacy data currently required. The FDA’s standards are working. Any effort to lower them could compromise the progress we’ve made in building physician and patient confidence in biosimilars.”

ASBM shared the survey findings with the FDA as part of a public comment period on draft guidance that proposes to lower the data requirements for demonstrating interchangeability. The U.S. Senate is also considering a bill that would deem all biosimilars interchangeable and severely restrict the FDA’s ability to ask for additional data.

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About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization of patients, healthcare providers, and manufacturers committed to ensuring that biosimilar medicines are introduced in the U.S. in a patient-centered way with transparent policies based on sound science and effective regulation. Learn more at www.SafeBiologics.org

Dr. McKibbin Op-ed: Lowering Interchangeable Biosimilar Standards Endangers Patient Health

October 5, 2024

Lower med standards endangers health

Altoona Mirror

Opinion

Oct 2, 2024

Dr. Ralph McKibbin

As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision.

When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of each patient.

Patients should have the confidence to make decisions about their care in partnership with their doctor, without the fear that insurance companies or pharmacies will override those choices for non-medical reasons such as increasing profitability.

Unfortunately, a proposed policy change threatens to undermine this relationship and could disrupt the treatment stability of patients across Pennsylvania.

Biologic medications are commonly prescribed to treat conditions like cancer, arthritis and Crohn’s disease — serious chronic conditions that require careful management. “Biosimilars,” which are designed to mimic these biologic medications, help create competition and lower costs.

While these drugs are safe and effective, they are not exact copies of the original biologics. Because of this, insurers or pharmacies can’t simply switch my patients to a biosimilar without my approval, unlike with generic drugs.

However, the FDA does allow some biosimilars to be designated as “interchangeable,” meaning that a pharmacist could substitute the biosimilar for the original biologic without needing approval from the prescribing doctor.

To receive this designation, manufacturers must submit additional data, which sometimes includes patient studies to prove that safety and effectiveness remain the same — even if a patient is switched between the original and biosimilar multiple times.

While nearly 9 in 10 physicians trust the safety of biosimilars, the majority (69%) believe that the decision of which medication to use should be made by patients and their doctors — not insurers or pharmacies.

This is because treatment is never one-size-fits-all. Many of my patients have had to try several medications before finding the one that best stabilizes their condition. Unnecessary or inappropriate switching risks disrupting this hard-earned stability.

That’s why 59% of doctors are more comfortable with biosimilar substitutions when the FDA designates them as interchangeable — it assures us that the switch won’t compromise our patients’ health.

Congress, including Pennsylvania Sen. Bob Casey, is considering whether or not to remove these important safeguards.

The Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable, allowing insurance companies to switch patients to any biosimilar without prior physician approval — even if it hasn’t been demonstrated to the FDA that such switching won’t jeopardize treatment stability.

The bill would also effectively strip the FDA of its ability to request studies on switching, weakening the standards that currently protect patients.

It’s no surprise that doctors across the country overwhelmingly oppose these changes. A recent survey of 270 U.S. physicians who prescribe biologics showed that only 11% support classifying all biosimilars as interchangeable, and 88% believe that switching studies increase their confidence of safely switching their patients to biosimilars.

As physicians, our primary concern is our patients’ health and safety.

It is Congress’s responsibility to maintain the rigorous standards for biosimilar interchangeability that have protected patients, earned doctors’ trust, and saved our healthcare system $24 billion.

Failing to do so would put patient health at risk and erode physician confidence in these vital treatments.

Dr. Ralph McKibbin, MD, FACP, FACG, AGAF, is the chairman of the Alliance for Safe Biologic Medicines, and a Pennsylvania-based gastroenterologist. He serves as Clinical Assistant Professor of Gastroenterology at Duquesne University College of Osteopathic Medicine; and Director at Pennsylvania Society of Gastroenterology.