Home » Articles » Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health

Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health

Published on 25 March 2025

Introduction: In the US, some biosimilars that meet additional requirements may be approved as interchangeable products. This means they can undergo pharmacy-level substitution. An online webinar titled ‘Biosimilar Red Tape Elimination Act (S.2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health’, was held to discuss its implications on medicines availability, safety and efficacy. It highlighted that the bill would class all biosimilars as interchangeable. Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) on 31 October 2024. A number of expert speaker presentations were followed by a Q&A with the panel, and the audience also had the opportunity to ask questions online throughout the webinar. Results: Presentations examined the current status of biosimilars and interchangeable biosimilars in the US, highlighting contrasts with Europe. The results of a recent prescriber survey on biosimilars and confidence in their use were outlined. The Biosimilar Red Tape Elimination Act (S.2305) was also presented and discussed. Perspectives from physicians, pharmacists, regulators, and patients on the legislation were explored, and shortcomings of the bill were highlighted. Additional details from the presentations were addressed during the Q&A session. Conclusion: The webinar facilitated an in-depth discussion about Biosimilar Red Tape Elimination Act and highlighted its shortcomings, particularly regarding the designation of all biosimilars as interchangeable.

Submitted: 7 March 2025; Revised: 10 March 2025; Accepted: 12 March 2025; Published online first: 25 March 2025

Introduction

In the United States, a rigorous biosimilars approval pathway has been established. Additionally, some biosimilars that meet specific requirements may be approved as interchangeable products, meaning they can undergo pharmacy-level substitution. At the time of the webinar, only a few biosimilars had been designated as interchangeable [1].

The Biosimilar Red Tape Elimination Act seeks to classify all biosimilars as interchangeable [2, 3], citing this as the status quo in Europe. However, it fails to highlight that the definition of ‘interchangeable’ differs between Europe and the US, and that pharmacy-level substitution in Europe almost never occurs.

The general consensus among key stakeholders – physicians, pharmacists, and patients – is that the bill could weaken US Food and Drug Administration (FDA) regularity standards, undermine physician confidence, and jeopardize patient health.

A thorough discussion and outlining of the bill’s implications are necessary moving forward.

Methods

In this online event, held on 31 October 2024, the contributors aimed to educate policymakers, healthcare providers, and patients on the current regulatory framework for biosimilars in the US [4]. They emphasized the importance of maintaining the US FDA’s robust approval standards for interchangeable biosimilars and highlighted the potential risks to patient safety and treatment efficacy that could arise from lowering those standards.

The webinar was introduced by Michael S Reilly, Esq, Executive Director of Alliance for Safe Biologic Medicines (ASBM). Expert presentations were delivered by Ralph McKibbin, MD, FACP, FACG, AGAF, Chair of ASBM, USA; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP from the College of Pharmacy, Ohio State University, USA; and Andrew Spiegel, Esq, Executive Director of the Global Colon Cancer Association, USA.

Results

Expert Speaker Presentations

There were several expert speaker presentations, followed by a Q&A session and an in-depth panel discussion.

Physician perspectives

Dr Ralph McKibbin opened the webinar by explaining how biosimilarity is established through the abbreviated pathway in the US [5]. He noted that a biosimilar is a biological that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biological medication (the ‘reference product’). The goal of a biosimilar development programme is to demonstrate biosimilarity between the proposed biosimilar and its reference product, rather than to independently establish the safety and effectiveness of the proposed biosimilar. This typically means that biosimilar manufacturers are not required to conduct as many expensive and lengthy clinical trials. The abbreviated pathway involves an extensive structural and functional comparison of the biosimilar to the reference product.

Regarding the data requirements for biosimilarity, FDA evaluates each biosimilar on a case-by-case basis and advises manufacturers on the scope and extent of testing needed to demonstrate biosimilarity. There is no one-size-fits-all approach to biosimilar product development. Analytical studies play a key role in establishing structural and functional similarity.

Other studies may include:

• Animal studies for toxicology or pharmacology information.
• Clinical pharmacology studies to demonstrate that the proposed biosimilar moves through the body in the same way and provides the same effects as the reference product.
• Additional clinical studies to address any remaining uncertainty about whether the proposed biosimilar has no clinically meaningful differences from the reference product.

In terms of interchangeable biosimilars, McKibbin noted that biosimilar products that meet additional requirements may be approved as interchangeable products, meaning they can be substituted for the reference product at the pharmacy level, depending on state pharmacy laws. He highlighted that, in all 50 states, only interchangeable biosimilars may be substituted without prior physician authorization. For these products, in addition to establishing biosimilarity, the manufacturer must demonstrate that switching between the two products would not increase safety risks or decrease effectiveness. This may be done through a switching study, in which a patient alternates between the reference product and the interchangeable product multiple times over a specific period. FDA has the flexibility to determine whether a switching study is necessary, based on the data provided by the manufacturer. At the time of the webinar, there were 14approved interchangeable biosimilars available [1]. Dr McKibbin noted that, for some products, FDA has required switching studies, while for others it has not [6].

In addition, it was highlighted that several physician groups have supported the FDA guidance [7] (from the American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations) [8].

In addition, it was highlighted that several physician groups—including the American Association of Clinical Endocrinologists, the American College of Rheumatology, the American Gastroenterological Association, the Biologics Prescribers Collaborative, and the Coalition of State Rheumatology Organizations [7] —have supported the FDA guidance [8].

However, it is important to recognize that definitions in the US differ to those in Europe. The term ‘interchangeable’ means ‘substitutable by the prescriber’. In the US, as in Europe, ALL BIOSIMILARS are substitutable by the prescriber. The US ‘interchangeable biosimilar’ category refers to biosimilars that are also substitutable by a pharmacist, due to additional data provided to FDA showing that switching to the biosimilar will not impact the safety or efficacy for the patient. Automatic pharmacy substitution of biosimilars in Europe is rare and often banned.

Dr McKibbin highlighted the results of a 2021 survey (n = 401) of US physicians [9], wherein 92% expressed confidence in the safety and efficacy of biosimilars. Regarding comfort with biosimilars, this was high, with 89% of physicians having no concerns about prescribing biosimilars to new patients. Additionally, 80% of respondents are comfortable, to some degree, with switching a patient to a biosimilar. A strong majority (69%) of physicians agree it is very important – or critical – that the physician, in collaboration with the patient, decides which treatment option to use, rather than a third party.

The issue with biosimilars and interchangeables is that treatment plans are not universal, and one size does NOT fit all. In many cases, a patient goes through several rounds of trial and error with their physician to find the right treatment that works best for them. This process often takes several years, and this is the basis of the doctor‒patient relationship. As such, the majority of physicians – 58% – are not comfortable with third-party non-medical switching for a patient who is stable on their current treatment. Despite this, survey results also showed that 57% were more likely to prescribe a biosimilar that is interchangeable; 59% were more comfortable with an interchangeable being substituted in place of the prescribed originator product. In other words, the ‘Interchangeable’ designation increases physician comfort with prescribing and substitution.

Dr McKibbin also presented the results of the ASBM 2024 Survey [10] on physician perspectives on interchangeable biosimilars. The survey finds that physicians strongly oppose provisions of the Biosimilar Red Tape Elimination Act.

Study summary:

• 270 participants
• All participants practice medicine in the United States
• 9 practice areas were included: Dermatology, Endocrinology, Gastrointestinal, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology
• Respondents distributed roughly equally between practice areas.

Eighty-seven per cent of respondents agreed that they are more comfortable switching a patient from an originator biological to a biosimilar if the 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 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. 88% of respondents agreed that biosimilar switching studies increase their confidence in the safety of moving patients from an originator medicine to the biosimilar that has been studied and determined to be interchangeable with the originator.

Development of US state biosimilar substitution policy

Professor Philip J Schneider commenced by describing that, for biosimilar substitution to be enabled, each of the 50 states’ Pharmacy Practice Acts in the US needed to be updated. This required collaboration and compromise among many stakeholders, including physicians, pharmacists, insurers, patient groups, and manufacturers. The final laws reflected this negotiated compromise and were widely supported by state medical societies.

In Europe, physicians are free to choose from all available products, including originators and biosimilars. Some countries encourage starting patients on the lowest-cost product, often biosimilar. The decision to switch to a biosimilar is made by the physician. In nearly every Western European country, automatic substitution of biosimilars at the pharmacy level is prohibited.

However, in the US, the ASBM and its members worked for eight years across 50 states in support of the Automatic Substitution Legislation, from 2013 to 2021. Physicians were initially reluctant to support any automatic substitution of biologicals, and pharmacists felt the notification requirements were onerous. Finally, in 2021, the key features agreed upon for legislation were:

• Only INTERCHANGEABLE BIOSIMILARS will be automatically substituted
• Physicians are able to prevent a substitution they feel is inappropriate (DAW ‒ Dispense as Written)
• Pharmacists must communicate to physicians within 3–5 days that a substitution has occurred (maintain accurate patient record).
• Patient notification required in many states.

All states now recognise the difference between interchangeable and non-interchangeable biosimilars, but state laws can be amended. For example, in 2023 Oregon’s Prescription Drug Advisory Board (PDAB) recommended that their legislature should add language permitting a non-interchangeable biosimilar to be substituted by a pharmacist without contacting the prescriber before dispensing the drug [11].  This would change the existing state law only allowing interchangeable biosimilars to be substituted for the reference product by the pharmacist.

In summary, Professor Schneider added that a lot of work has been done to enable pharmacists and physicians to work together in managing the cost of biologicals and the use of limited healthcare resources, without jeopardizing the effectiveness or safety of therapy. This required significant effort but resulted in a system that is now working.

Regulatory perspective

Mr Michael Reilly began by introducing the US Senate Bill 2035, the Biosimilar Red Tape Elimination Act, brought forward by Senator Mike Lee [2]. Mr Reilly stated that the generic equivalent of a biological drug is known as a biosimilar. Unlike generic drugs, many states will not allow pharmacists to substitute a biosimilar unless the FDA declares it to be ‘interchangeable’. He emphasizes that the announcement of the bill makes numerous factual errors, essentially says that biosimilars are generics and fails to acknowledge the important differences between them.

The announcement of the bill states that ‘After examining 15 years of data, the European Medicines Agency (EMA) recently stated that switching studies are unnecessary for biosimilars to obtain interchangeable status’ [12]. However, it fails to point out that the European definition of ‘interchangeable’ means ‘substitutable by the prescriber’. In the US, as in Europe, all biosimilars are substitutable by the prescriber. The US ‘interchangeable biosimilar’ category refers to biosimilars that are also substitutable by a pharmacist, due to having provided additional data to FDA showing that switching to the biosimilar will not impact the safety or efficacy for the patient. Automatic pharmacy substitution of biosimilars, as the bill would allow, in Europe is rare and often prohibited [13].

According to Mr Reilly, the Biosimilars Red Tape Elimination Act is not what it seems. It classifies all biosimilars as interchangeable without requiring additional data, effectively treating them as generics. Moreover, it also restricts FDA’s ability to request data for scientific determinations in interchangeable biosimilar approvals and circumvents the limits on automatic substitution imposed by laws passed in 50 states.

The bill claims to ‘improve the requirements for making a determination of interchangeability of a biological product and its reference product’. However, Mr Reilly argues that the bill achieves the opposite, undermining these requirements rather than enhancing them. Specifically, the bill introduces a presumption that an approved biosimilar is interchangeable with the reference product without requiring additional evidence from the manufacturer. It also eliminates exclusivity periods for the first interchangeable biosimilar, i.e. a product that is the first interchangeable biosimilar to be approved with respect to the reference product.

In this context, Mr Reilly highlights key questions that should be considered:

• Doesn’t the fact that FDA is supporting this mean it is a good idea?
• Why is there no opposition from physician groups?

And overall,

• Why is the FDA supporting legislation that strips its discretionary authority?

The bill’s support is largely attributed to the results of an FDA meta-analysis conducted in 2023, titled ‘Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis’ [14, 15]. This analysis is frequently referenced by advocates of adopting a generics-style substitution model for biosimilars. It is also cited in the June 2024 FDA updates guidance on interchangeability [16], which downplays the importance of switching studies for interchangeability. The meta-analysis concludes there is ‘insignificant risk’ of safety or efficacy issues when switching between reference and biosimilar products. However, meta-analyses are not without controversy, and their criticisms and limitations have been acknowledged:

• Quality of included studies: dependence on the quality of included studies can amplify existing flaws.
• Heterogeneity: variability in study designs and populations may hinder valid conclusions.
• Publication bias: overrepresentation of studies with positive results skews overall findings.
• Selection bias: subjective choices in study selection can introduce bias.
• Data overlap: inclusion of duplicated data can distort results.
• Apples to oranges: combining dissimilar studies can lead to inappropriate conclusions.
• Statistical issues: choices in statistical modeling can significantly influence outcomes.
• Oversimplification: potential to obscure complex details and variations between studies.
• Conflicts of Interest: biases due to researchers’ affiliations or beliefs can affect outcomes.
• Overinterpretation: results may be viewed as definitive when they are only part of the evidence.

The ASBM Whitepaper [17] raises concerns about the FDA meta-analysis [14]. Both Dr McKibbin and Mr Reilly noted that the FDA analysis is highly selective and limited, including only 44 randomized controlled trials and their extension studies. Furthermore, efficacy impacts are not evaluated, only safety. It is noted that FDA regulatory approval for interchangeable biosimilar products is based on demonstrating that neither safety nor treatment efficacy are negatively affected. The study also inappropriate pools data from studies across therapeutic areas without grouping them by individual therapies, indications, or the number of switches. Additionally, it extrapolates multi-switch safety data primarily from single-switch studies, with 64% of the studies being single-switch. Finally, it neglects real-world considerations, such as patient variability.

In April 2024, an Endpoints News interview with an FDA official was published. In the interview, Dr Sarah Yim, Director of the FDA’s Office of Therapeutic Biologics and Biosimilars called on Congress to eliminate the regulatory distinction between interchangeable and non-interchangeable biosimilars. Dr Yim stated that this change is now necessary because there are no longer any scientific or clinical reasons to difference between the two classes of products. She explained, ‘Instead of having two different levels of similarity, for example, we don’t feel like we can implement that’.

In October 2024, Inside Health Policy published an article stating, ‘Accumulated scientific evidence has led FDA to conclude clinical studies are mostly unnecessary to determine whether a biosimilar drug should be interchangeable with its reference product’; and ‘FDA’s accrued experience with switching between reference products and biosimilars, and global post-approval data, have not demonstrated clinical concerns with the practice; the officials say this provides support for the idea that a switching study is not necessary in most cases’; and ‘we were able to approve the majority (9/13) of interchangeable products without the need for a clinical switching study’.

The Association for Accessible Medicines (AAM) told Inside Health Policy that the interchangeability bill has bipartisan support and is a policy endorsed by the FDA, the Federal Trade Commission, and state governments. The bill’s original bipartisan cosponsors, including Senator JD Vance (R-OH), who at the time of the Webinar was the Republican nominee for Vice President, said the change to eliminate additional interchangeability studies would increase patient and provider confidence in biosimilars and result in lower prices for patients.

However, in the 2024 prescriber survey [10] described in Dr McKibbin’s presentation, 88% of respondents agreed that biosimilar switching studies increase their confidence in the safety of transitioning patients from an originator medicine to a studied biosimilar determined to be interchangeable with the originator. This stands in contrast to the Lee bill.

Overall, Mr Reilly summarized that the flawed legislation is based on two false premises:

• Biosimilars are generics – they are not.
• This policy would align US with Europe, where automatic pharmacy substitution of biosimilars is rare and often prohibited.

The bill is supported by a weak study with flawed methodology. Physicians, when informed, overwhelmingly oppose the bill’s intent (deeming all biosimilars interchangeable). The bill’s primary supporters are payers, such as Pharmacy Benefit Management (PBM) Industry Trade Group and ERISA Industry Committee (representing large, self-insured employers).

In conclusion, Reilly remarked that the conversation on Capitol Hill is focused on how the proposed savings can be used to ‘pay for’ other programmes. However, he emphasized that we should not engage in bartering and horse-trading when patient safety is at stake.

Patient perspective

Mr Andrew Spiegel started by expressing that patient advocates were deeply concerned about recent legislative proposals, which they believe threaten to undermine years of efforts to safeguard patient safety and healthcare decision-making. A representative from a patient organization expressed their opposition to politicians making personal healthcare decisions on behalf of patients. They instead stressed the importance of relying on FDA to approve drugs based on rigorous safety, effectiveness, and data-driven standards, with physicians playing a central role in determining individual treatments.

From 2013 to 2021, Mr Spiegel and patient advocates travelled across the US to ensure the passage of pharmacy legislation in all 50 states. These laws were said to prioritize patient safety, particularly regarding biologicals and biosimilars, which are distinct from generic drugs. Advocates testified nationwide, addressing concerns that pharmacists, rather than physicians, might substitute medications without sufficient knowledge of a patient’s medical history. However, the laws that were ultimately passed included provisions ensuring that substitution decisions were backed by robust data, such as switching studies, which reassured both physicians and patients.

Mr Spiegel explained that this new bill, if enacted, would undo nearly a decade of hard work. It was argued that the bill betrayed promises made to patients, physicians, and policymakers who had worked together to pass state legislation protecting patient safety. The proposed law, which introduced congressional approval for data used in FDA determinations, was described as unprecedented and unnecessary.

This legislation jeopardizes the trust built over the years and the agreements made to prioritize patient welfare. MrSpiegel urges policymakers to recognize the harm this law could cause, calling it a betrayal of patient rights and a reversal of critical advancements in healthcare policy. He emphasized that the patient community strongly opposed political interference in healthcare decisions and reiterated the need for such decisions to remain within the domain of scientific and medical experts.

Summary of panel discussion and Q&A

Following the expert presentations, the panel members discussed several questions.

The discussion on proposed legislation concerning the automatic interchangeability of biosimilars revealed significant concerns among healthcare professionals, patient advocates, and policymakers. Below is a summary of the key questions raised during the debate and subsequent discussion.

Question 1: What is the impact of the legislation on biosimilars and substitution laws?

Mr Spiegel outlined that the proposed bill would ‘deem’ all biosimilars interchangeable, effectively overriding existing state legislation that permits automatic substitution only for FDA-designated interchangeable biosimilars. It was emphasized that such automatic substitution would occur across all 50 states, potentially undermining years of work that prioritized patient safety.

Question 2: Why are physicians not speaking up about the legislation?

Dr McKibbin responded by noting that many physicians were unaware of the proposed legislation and its implications. He emphasized the need for better awareness among clinicians regarding the potential risks posed by automatic substitution without sufficient data to ensure safety and efficacy.

Question 3: What role does data quality play in biosimilar approval?

Dr McKibbin stressed the importance of robust data in healthcare decision-making. He explained that clinical guidelines now evaluate the strength and quality of data to support recommendations. The proposed legislation, he argued, overlooks the nuances of subgroup-specific data and risks oversimplifying biosimilar substitution by treating patients as ‘interchangeable Lego pieces’.

Question 4: How does the legislation impact trust within the healthcare community?

Professor Schneider argued that trust between physicians, pharmacists, and patients could be eroded by legislation that bypasses evidence-based processes. He expressed concerns that healthcare decisions might be dictated by political interests rather than patient-centric needs, ultimately undermining the doctor-patient relationship.

Question 5: What lessons can be learned from international perspectives on biosimilar interchangeability?

Mr Reilly shared insights from discussions with regulators in Europe, Canada, and Australia. He noted that while these regions often consider all biosimilars interchangeable, the US system’s emphasis on additional data for FDA-designated interchangeable biosimilars provides a critical advantage. He cautioned against dismantling this system, which has proven beneficial for patient confidence.

Question 6: What are the concerns about cost overshadowing safety and effectiveness?

Mr Spiegel highlighted that while cost is an important consideration, patient safety and treatment efficacy should remain the priority. He argued that FDA prioritizes safety and effectiveness, whereas Congress seems to focus more on cost, potentially compromising patient care.

Question 7: How should patients be reassured about biosimilar interchangeability?

Mr Reilly explained that building patient confidence in biosimilars requires open communication and informed consent. He emphasized that biosimilars, when supported by sufficient data, are as effective as originator biologicals. However, switching decisions should be personalized based on a patient’s medical history and comorbidities. He encouraged collaboration among stakeholders to foster trust and raise awareness.

Question 8: What is the broader impact of this legislation?

The panelists collectively expressed concerns that the bill would disrupt a carefully established system of biosimilar regulation. They emphasized that existing state laws were designed to protect patients by ensuring interchangeability decisions were backed by robust evidence. The proposed legislation was described as a ‘bait and switch’ that could upend these safeguards and compromise the role of healthcare providers in making informed decisions.

Question 9: In your opinion, what is the best way to explain ‘interchangeability’ to patients, especially for those who are already apprehensive about using biosimilars? As patient organizations, we need to ensure they understand what this means while also helping them feel confident about the use biosimilars.

Professor Schneider advised that the pharmacist could explain the process of assuring both safety and effectiveness based on clinical studies that are usually done before FDA determines that a biosimilar is interchangeable with the reference product. This added requirement for an interchangeability designation was expressly intended to promote public confidence.

Dr McKibbin believes that decision-making is based on transparency and the discussion of risks and benefits.  Every patient is unique and a blanket one-size-fits all approach does not work.  There is a very broad range of disease presentations, risk factors such as age and other medical conditions as well as individual experiences with medicines.  Concerns such as side effects, loss of efficacy, medication lot tracking, immunogenicity are commonplace as seen in the daily news about such things as product contamination and recalls. Safety is a process, not a place.  Every prescriber should have the fund of knowledge to explain the biosimilar approval process and its assurance of safety and efficacy. The additional data requirements for the interchangeable designation are very beneficial, especially for our complex and high-risk patients.

Conclusion

The webinar provided important insights on key elements of the Biosimilar Red Tape Elimination Act (S.2305). In particular, it emphasized that the bill would classify all biosimilars as interchangeable and thus substitutable at the pharmacy level. As a result, the act could weaken FDA regulatory standards for biosimilars, undermine physician confidence, and jeopardize patient health. The debate also showcased widespread opposition to the proposed legislation from healthcare professionals and patient advocates.

Panelists underscored the importance of preserving evidence-based decision-making, protecting the doctor‒patient relationship, and maintaining trust in biosimilar treatments. The overarching consensus was that patient safety and treatment efficacy should remain the guiding principles in healthcare policy.

Speaker Faculty and Panelists

Ralph D McKibbin, MD, FACP, FACG, AGAF
Michael S Reilly, Esq
Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
Andrew Spiegel, Esq

Editor’s comment

Speakers and moderator had provided feedback on the article content and panel discussion, read and commented the revised content of the manuscript, and approved the final report for publication.

Readers can watch replay of the Biosimilar Red Tape Elimination Act webinar via this link: https://youtu.be/X6-dYZ7fjhM

Funding sources

The article was funded by the Alliance for Safe Biologic Medicines (ASBM).

ASBM is a coalition of patient advocacy organizations, physicians, pharmacists, biopharmaceutical manufacturers, and others working to advance patient-centred health policy at the state, federal, and international level. Visit www.SafeBiologics.org to learn more.

Competing interests: Mr Michael S Reilly, Esq is the Executive Director and employed by Alliance for Safe Biologic Medicines. Mr Reilly served in the US Department of Health and Human Services from 2002 to 2008.

Provenance and peer review: Not commissioned; internally peer reviewed.

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Author for correspondence:: Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines, PO Box 3691, Arlington, VA 22203, USA

Disclosure of Conflict of Interest Statement is available upon request.

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