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.

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.

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

September 27, 2024

Prioritize Patient Treatment Stability, Physician Confidence

Michael Reilly
September 25, 2024

Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. To date, 59 biosimilars have been approved and have saved our health system $24 billion. The FDA’s approval standards have rightly earned physician and patient trust. Unfortunately, Congress is now considering weakening those standards – which could inadvertently jeopardize the health of millions of patients and with it, confidence in these medicines.

While safe and effective, biosimilars aren’t generics because they aren’t identical copies of a biologic. Insurance companies and pharmacy benefit managers (PBMs) cannot treat biosimilars like generics and simply switch a patient to their preferred version, usually the more profitable medication. Under state law in all 50 states, only “interchangeable” biosimilars may be substituted by a third-party without prescriber approval. Interchangeables have demonstrated to the FDA through data, including switching studies, that a patient can expect the same results with no additional risks, even after multiple switches, compared to a patient who remained on the original biologic.

Surveys show nearly all physicians – 89% – are confident in biosimilars. Nevertheless, 69% believe that patients and physicians should control the decision to switch medications, not insurers and pharmacists. That’s because treatment plans aren’t universal; they are as individual as patients themselves. Patients often try several different medicines before finding the one that works best to treat their condition. An interchangeable designation makes almost 60% of physicians more comfortable with a biosimilar substitution at the pharmacy, knowing a stable patient won’t be put at risk by third party-switching.

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.

Both policies are strongly opposed by the clinicians who best understand these medicines. A recent survey of 270 physicians who prescribe biologics revealed that a mere 11% believe all biosimilars should be classified as interchangeable, and 88% said biosimilar switching studies increase their confidence in safe switching.

Congress has a responsibility to retain the rigorous standards for interchangeability that have kept U.S. patients safe, earned the trust of physicians, and lowered health care costs. A failure to do so will put patient health outcomes, and physician trust in these important medicines, in jeopardy.

Michael Reilly served in the Office of the Secretary of the U.S. Department of Health and Human Services from 2002-2008, including three years as Associate Deputy Secretary. He serves as Executive Director of the Alliance for Biologic Medicines and resides in Alexandria, VA.

Read the oped at RealClearHealth

Fact Sheet: Physicians Oppose S.2305 -That Would Make All Biosimilars Interchangeable

August 27, 2024

In August, ASBM released an updated fact sheet on Senate Bill S. 2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Mike Lee (R-UT), shoing how physicians overwhelmingly oppose its provisions. view it here: https://safebiologics.org/wp-content/uploads/2024/09/IC-RedTape-1p-FNL2.pdf

From the Fact Sheet:

U.S. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% also say the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. That’s because treatment plans aren’t one-size-fits-all. 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 the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance, making a majority (59%) of U.S. physicians more comfortable with a pharmacy-level substitution.

From 2013-2021 all 50 state legislatures passed laws restricting automatic pharmacy substitution of biosimilars ONLY to interchangeable biosimilars. These laws were passed with the support of state medical
societies and patient organizations, conditional on these limits.

S.2305 would classify ALL biosimilars as interchangeable-inappropriately
permitting generic-style pharmacy substitution by insurance companies and pharmacy benefit managers, without the safety and efficacy data now needed. This would jeopardize treatment stability for millions of patients and betray the assurances made to physicians and patients nationwide that only biosimilars which had provided additional safety and efficacy data would ever be substituted without physician approval.

It would also restrict what data FDA can ask for to approve an interchangeable biosimilar, requiring the HHS Secretary to hold a private briefing with the chairs and ranking members of the Senate HELP and House Energy and Commerce Committees to justify asking for a study demonstrating switching won’t reduce safety or efficacy in patients.

Read the full Fact Sheet here.

S2305BSRedTape Download

ASBM Submits Comments on FDA Draft Guidance Proposing Eliminating Switching Studies for Interchangable Biosimilars

August 27, 2024

On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.

From ASBM’s comments:

In addition to the FDA Draft Guidance, several legislative and regulatory proposals have been introduced at the state and federal level that would reduce requirements for interchangeability, declare all biosimilars interchangeable (making all biosimilars pharmacy-substitutable in the manner of generics), and/or restrict the FDA’s use of switching studies in determining interchangeability. Data has shown, however, that these policies are strongly opposed by physicians who prescribe biologics.

A 2024 survey of 270 U.S. physicians shows the importance of maintaining the robust data requirements undergirding the interchangeable designation. Respondents were drawn from nine practice areas: Dermatology, Endocrinology, Gastrointestinal, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology. All prescribe biologics.

87% of respondents agreed that they are more comfortable switching a patient from an originator biologic to a biosimilar if that medicine has been specifically evaluated for the impact of switching on safety and efficacy.
88% of respondents believe each interchangeable biosimilar should be individually evaluated specifically for the impact of switching on safety and efficacy.
Only 11% believe all biosimilars should be deemed interchangeable.
85% of respondents agreed that only biosimilars that have been individually evaluated specifically for the impact of switching on safety and efficacy should be deemed interchangeable.

These new data are consistent with previous findings demonstrating the value of the FDA’s current data standards for interchangeable biosimilars in providing assurances to physicians that third-party substitution will not impact safety or efficacy.

The role and value of switching studies in the approval of interchangeable biosimilars has been a subject of much discussion recently, and ASBM has generated several educational resources on the subject:

Read ASBM’s comments to the FDA here.

Read ASBM’s whitepaper about how misinformation regarding interchangeable biosimilars is undermining U.S. policy here.

View the webinar on Interchangeable Biosimilars here.

Read the article in GaBI Journal here.

June-July Newsletter

August 23, 2024

ASBM Whitepaper: Misinformation About Interchangeable Biosimilars Undermines US Health Policy, Physician Confidence, and Patient Health On July 16th, GaBI Journal published a whitepaper authored by ASBM Chairman Ralph McKibbin, MD and Executive Director Michael Reilly, which underscores the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health,” the paper discusses the successes of the FDA’s data-driven approach in building physician and patient confidence in biosimilars and provides an analysis of the potential risks associated with weakening these proven standards. In the U.S. as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S., only biosimilars deemed “interchangeable” by the FDA may be substituted by a pharmacist. 13 of the 53 approved biosimilars have earned that designation by providing additional data to the FDA demonstrating no loss of safety or efficacy even following multiple switches between a reference biologic and the biosimilar. This data may or may not include a switching study; several interchangeables have been approved without them. “All FDA-approved biosimilars are safe and effective, but treatment plans are not one-size-fits-all”, says McKibbin. “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 the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance.” “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”, notes Reilly. “These views are shared by physicians worldwide. But when a biosimilar carries an interchangeable designation, the majority (59%) of U.S. physicians are more comfortable with a pharmacy-level substitution because of the additional safety and efficacy data. The FDA’s standards are working, and any effort to lower them could compromise the progress we’ve made in building physician and patient confidence in biosimilars.” The publication of this paper comes at a critical time as the FDA seeks public comment on recent draft guidance that proposes to lower the data requirements for demonstrating interchangeability, and the U.S. Senate is considering a bill that would deem all biosimilars interchangeable and severely restrict the FDA’s ability to ask for additional data. The paper critically examines the recent meta-analysis often cited by proponents of lowering these standards. Focusing on safety but neglecting efficacy impacts and extrapolating multi-switch safety from mostly single-switch studies, McKibbin and Reilly argue the data do not support the proposed policy change. Read ASBM’s statement about the paper’s release here. Read the full paper here.

COMMENT PERIOD OPEN: FDA Draft Guidance Proposes Eliminating Switching Studies for Interchangable Biosimilars On June 20th, the FDA released new draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. In a statement, Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars said: “The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science.” From the FDA’s statement: FDA has generally recommended switching studies in the past as part of the data package needed to demonstrate interchangeability of a biosimilar; however, of the 13 approved interchangeable biosimilars, 9 were approved without additional clinical (switching study) data. With the publishing of today’s draft guidance, FDA is seeking comment on a revised approach where such studies will generally not be needed. The FDA is accepting public comment on the draft guidance from stakeholders until August 20, 2024. ASBM will be submitting comments and encourages others in the patient advocacy community to do so as well. Interested parties may submit their own comments here. The role and value of switching studies in the approval of interchangeable biosimilars has been a subject of much discussion recently, and ASBM has generated several educational resources on the subject. On November 30th, 2023 ASBM cohosted a webinar with GaBI November 30th on the topic. On May 10th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published an article by ASBM’s Executive Director Michael Reilly entitled “Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars”, which sought to address a recent push by U.S. policymakers to weaken or undermine the standard. In the article, Reilly explains the importance of additional data in building physician confidence: “The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.” Read ASBM’s whitepaper about how misinformation regarding interchangeable biosimilars is undermining U.S. policy here. View the webinar on Interchangeable Biosimilars here. Read the article in GaBI Journal here. Submit comments on the draft guidance by August 20, 2024 here.

ASBM Fact Sheet: Senate Bill S.2305 Would Require FDA to Deem ALL Biosimilars Interchangeable, Restrict FDA From Considering Switching Studies to Establish Safety and Efficacy After Switching In July, ASBM released a fact sheet on Senate Bill S. 2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Mike Lee (R-UT). From the Fact Sheet: S. 2305 would inappropriately eliminate the FDA safeguards now required for the pharmacy substitution of biosimilars. This would undermine physician confidence, risk treatment stability for millions of patients, and give PBMs and insurance companies control of treatment decisions that should be made by physicians and patients. U.S. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% also say the physician and patient should determine which biologic to use, not a third-party such as a pharmacy or insurance company. That’s because treatment plans aren’t one-size-fits-all. 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 the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance, making a majority (59%) of U.S. physicians more comfortable with a pharmacy-level substitution. From 2013-2021 all 50 state legislatures passed laws restricting automatic pharmacy substitution of biosimilars ONLY to interchangeable biosimilars. These laws were passed with the support of state medical
societies and patient organizations, conditional on these limits.
S.2305 would classify ALL biosimilars as interchangeable-inappropriately
permitting generic-style pharmacy substitution by insurance companies and pharmacy benefit managers, without the safety and efficacy data now needed. This would jeopardize treatment stability for millions of patients and betray the assurances made to physicians and patients nationwide that only biosimilars which had provided additional safety and efficacy data would ever be substituted without physician approval.
It would also restrict what data FDA can ask for to approve an interchangeable biosimilar, requiring the HHS Secretary to hold a private
briefing with the chairs and ranking members of the Senate HELP and
House Energy and Commerce Committees to justify asking for a study
demonstrating switching won’t reduce safety or efficacy in patients. Read the full Fact Sheet here.

ASBM to Update Ohio State University Biosimilars Course In the coming weeks, ASBM will announce updates to its 7-part Biosimilars Continuing Education Course produced in cooperation with Ohio State University College of Pharmacy. ASBM Chairman Ralph McKibbin and Advisory Board Chair Philip Schneider will be recording the first of the updated course modules (Biosimilars Module 2: Substitution and Interchangeability) in the coming weeks. The course is fully ACPE-accredited and available to pharmacists nationwide for 7 hours of CE credit. “Much has happened in the past year or two regarding biosimilar substitution; particularly regarding the role of interchangeable biosimilars,” said Schneider. “As the healthcare provider responsible for substitution, it’s important that pharmacists are kept up to date with accurate information.” Schneider, a professor at OSU’s College of Pharmacy, will also record a 5-minute promotional video for the course, previewing some of the updates regarding interchangeable biosimilars. ASBM will share this video when it becomes available.

BIO 2024: ASBM Participates in Annual Biotechnology Conference From June 3rd-6th, the Biotechnology Innovation Organization held its Annual International Conference in San Diego, CA. ASBM was well represented at the conference, with several member groups in attendance including AiArthritis, the Alliance for Patient Access, and the Lupus and Allied Diseases Association. Executive Director Michael Reilly also attended in the conference, where he participated in educational sessions and met with representatives of the biotechnology industry and patient advocacy communities. A key topic of discussion included the effects of the Inflation Reduction Act (IRA), which is expected to disincentivize drug research in the coming years, ultimately reducing patient access to new innovative therapies. ASBM has developed a number of educational resources discussing these themes: View ASBM’s IRA patient education microsite IRAPatientInfo.org here. View ASBM’s educational resource guide on the IRA for patient access here.

Forbes: IRA’s Small Molecule Price Controls Are Short Sighted On June 24, Forbes published an op-ed by Pacific Research Institute President Sally Pipes discussing the IRA’s highly controversial “small molecule penalty” and in particular its negative consequences for cancer research: AstraZeneca’s Tagrisso “can contain lung cancer nearly three years longer than chemotherapy and radiation alone.” Pfizer’s Lorbrena helps keep 60% of advanced lung cancer patients “alive without their disease advancing at five years,” compared to just 8% of patients who hit that milestone after taking a similar, older drugs.We’re likely to see fewer of these innovative drugs hit the market in the years to come, thanks to the Democrats’ Inflation Reduction Act, which President Biden signed into law in 2022. Starting in 2026, ten drugs under Medicare’s Part D prescription drug benefit will be subject to government price controls. Medicare will cap the prices of steadily more drugs dispensed via Part D and the Part B physician services program in the years that follow.Companies that refuse to sell at government-ordered prices may either withdraw from Medicare and Medicaid — a non-starter given that the government covers roughly half of all healthcare expenses. Or they can pay an excise tax that could reach up to 95% of the drug in question’s sales.Price controls are disincentive enough to invest in the development of new cancer drugs. But the IRA also targets the types of drugs that most commonly treat cancer for price controls four years sooner than it does biologics. Read the full op-ed here.

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

UPCOMING EVENTS ACR Convergence 2024
Washington, DC – November 14-19, 2024 WHO 79th INN Consultation
Geneva, Switzerland – October 22, 2024

Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health

July 16, 2024

WASHINGTON, July 16, 2024 – The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health,” the paper discusses the successes of the FDA’s data-driven approach in building physician and patient confidence in biosimilars and provides an analysis of the potential risks associated with weakening these proven standards.

In the U.S., as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S., only biosimilars deemed “interchangeable” by the FDA may be substituted by a pharmacist. Thirteen of the 53 approved biosimilars have earned that designation by providing additional data to the FDA demonstrating no loss of safety or efficacy even following multiple switches between a reference biologic and the biosimilar. This data may or may not include a switching study; several interchangeables have been approved without them.

ASBM Chairman and paper co-author Ralph McKibbin, MD: “All FDA-approved biosimilars are safe and effective, but treatment plans are not one-size-fits-all. 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 the patient’s treatment stability. The interchangeable standard’s data requirements provide that assurance.”

ASBM Executive Director and paper co-author Michael S. Reilly: “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. These views are shared by physicians worldwide. But when a biosimilar carries an interchangeable designation, the majority (58%) of U.S. physicians are more comfortable with a pharmacy-level substitution because of the additional safety and efficacy data. The FDA’s standards are working, and any effort to lower them could compromise the progress we’ve made in building physician and patient confidence in biosimilars.”

The publication of this paper comes at a critical time as the FDA seeks public comment on recent draft guidance that proposes to lower the data requirements for demonstrating interchangeability, and the U.S. Senate is considering a bill that would deem all biosimilars interchangeable and severely restrict the FDA’s ability to ask for additional data. The paper critically examines the recent meta-analysis often cited by proponents of lowering these standards. Focusing on safety but neglecting efficacy impacts and extrapolating multi-switch safety from mostly single-switch studies, McKibbin and Reilly argue the data do not support the proposed policy change.

Reilly attributes the push to weaken the current standard to widespread misconceptions and misinformation about interchangeability: “Some incorrectly believe switching studies are mandated by the FDA for a biosimilar to be deemed interchangeable, when in fact the FDA has flexibility and approved several without switching studies. Others confuse European Medicines Agency’s definition of “interchangeable” (meaning physician-substitutable) with the U.S. definition (meaning pharmacist-substitutable) and incorrectly believe the proposed policy change would bring the U.S. in line with Europe. In reality, pharmacy substitution of biosimilars is rare in Europe and frequently banned by EU member states. Accurate information and education are critical to avoid policy missteps that will undermine the FDA’s success in building physician confidence in biosimilars and protecting patients’ health.”

The full paper can be accessed in the latest issue of the Journal of the Generics and Biosimilars Initiative (GaBI Journal) here.

May 2024 Newsletter

June 7, 2024

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM was well represented at the conference, with several member groups were in attendance including the International Cancer Advocacy Network (ICAN), and the Global Colon Cancer Association (GCCA). Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. In conjunction with ASCO 2024, ASBM released a resource guide for the cancer community, which assembles a variety of ASBM-created educational content detailing the IRA’s effects. These include a webinar featuring an analysis of the policy by former government health officials responsible for developing and implementing Medicare’s prescription drug benefit, a podcast episode, a research paper, a fact sheet, and a patient-education microsite. View the resource guide here.

ASBM Discusses Biosimilar Interchangeability and Substitution at Oregon’s St. Charles Health System Grand Rounds On May 17, ASBM Executive Director Michael Reilly led a Grand Rounds at St. Charles Health System focused on biosimilar interchangeability and substitution. The Bend, OR-based health system is the state’s largest. Among the topics Reilly covered were recent efforts at the state, federal, and international level to eliminiate the distinction between biosimilars (which may be substituted in place of their reference product by a prescribing physician) and interchangeable biosimilars, which may be substituted under state laws by a pharmacist. Interchangeables have earned this classification by providing additional data to the FDA demonstrating that neither safety nor efficacy diminish for patients, even after repeated switching, relative to patients who remained on the reference product. This discussion is particularly relevant for Oregon healthcare providers as last year, the states’s Prescription Drug Affordability Board (PDAB) recommended the Oregon legislature alter state law to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe.Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. ASBM submitted comments opposing the proposal and defending the current state law. From the comments: As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients. View Mr. Reilly’s Grand Rounds presentation here. Read ASBM’s comments on the OR PDAB legislation here.

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars
On May 10th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published an article by ASBM’s Executive Director Michael Reilly entitled “Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars”. The article was written in a r esponse to an April article in EndpointsNews, in which an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to Reilly. The FDA official’s comments echoed language in the Administration’s FY2025 HHS Budget which alleges the interchangeable standard creates “confusion” among healthcare providers. On the contrary, Reilly explains, it creates confidence: The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.” Moreover, while the Administration claims eliminating the distinction would bring the U.S. more into line with European substitution practices, in fact the opposite is true: The EMA does not weigh in on pharmacy substitution of biosimilars; this is reserved for member states and nearly every Western European country has decided (like U.S. states) that this is not acceptable. A 2019 survey revealed a strong majority (73%) of Europe’s physicians, like their U.S. counterparts, oppose third-party biosimilar substitution. Finally, biosimilar uptake is largely determined by insurer and PBM formulary design, not a biosimilar’s interchangeable designation, Reilly explains. “CVS Caremark, which controls 34% of the market, recently dropped the reference adalimumab in favor of its own co-branded biosimilar version. Within a week, adalimumab biosimilar market share rose from 5% to 36%.” Cigna, a PBM controlling 24% of the U.S. market, has announced plans to make a similar move in June. “The interchangeable biosimilar standard is working as intended: building physician confidence through data and providing a biosimilar option physicians can be certain will not jeopardize the treatment stability of a patient for whom maintaining it is a critical concern.There are several promising bipartisan legislative effortsunderway in Congress bring more transparency to PBM formulary design and rebate practices. These represent a far more productive -and medically appropriate- target for reform efforts for those seeking to boost biosimilar uptake.” Read the article in GaBI Journal here.

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases On May 28th, the U.S. FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; andthe treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.“Many rare conditions are life-threatening, and many do not have treatments,” said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”
Read approval the FDA approval here.

FDA Approves First Interchangeable Biosimilars to Treat Macular Degeneration In May, the FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision. Both Yesafili and Opuviz are used to treat:Neovascular (wet) age-related macular degenerationMacular edema following retinal vein occlusionDiabetic macular edemaDiabetic retinopathyBoth Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the conditions listed above according to dosing regimens as recommended in the labeling. Read more about the FDA approvals here.

Pennsylvania Senate Introduces PBM Bill The Pennsylvania Senate Health and Human Services Committee recently unanimously amended SB 1000, An Act amending the act of November 21, 2016 (P.L.1318, No.169), known as the Pharmacy Audit Integrity and Transparency Act; It was introduced and referred to the Committee on January 8th of this year and has now been presented for first consideration. Senate Bill 1000 directs the Insurance Department to develop a process for hearing and resolving pharmacy complaints against a PBM. PBMs shall report to the department the amount of rebates and payments received from drug manufacturers, and how those rebates and payments were distributed by the PBM. The legislation will also limit or ban several practices by PBMs, including patient steering, spread pricing and retroactive recoupment of money paid by the PBM to the pharmacy. Read more about PA SB 1000 here.