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BioRationality: Questioning Experts and Journals Reporting on Biosimilar Bill to Remove Interchangeability
The debate over the Biosimilar Red Tape Elimination Act raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.
The peer-reviewed paper titled “Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health” published in March 20251,2 was based on a webinar held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI). The journal publishing this paper summarized the presentations made in this webinar, concluding that the Biosimilar Red Tape Elimination Act (S.2305) weakens the FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health. The authors of the paper reported they were clinicians presenting their analysis, which contradicted the FDA findings, commenting on the scientific rationale that is beyond the expertise of physicians. Of equal concern is the journal's partnership in arranging the webinar and publishing its results.
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The authors claimed that the ‘Biosimilar Red Tape Elimination Act (S.2305)3 would classify all biosimilars as interchangeable, highlighting its shortcomings, and the justification that similar acceptance in the European Union is common was questioned on the basis that the definition of ‘interchangeable’ differs between Europe and the US and that pharmacy-level substitution in Europe rarely occurs, an opinion that is incorrect and misleading. The presenters also suggested conducting animal toxicology or pharmacology studies, which have now been removed by the FDA, and clinical efficacy studies, which have also been removed by many agencies, including a prospective change at the US FDA. The views of presenters emphasized the need to conduct extensive additional studies to achieve interchangeable status, as perceived by 87% of webinar responders.
In April 2024, Sarah Yim, MD, 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. Yim stated that this change is now necessary because there are no longer any scientific or clinical reasons to differentiate between the two classes of products. She explained, “Instead of having 2 different levels of similarity, for example, we don’t feel like we can implement that.”4
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.”5
However, the ASBM Whitepaper raises concerns about the FDA meta-analysis.6,7 Both authors noted that the FDA analysis is highly selective and limited, encompassing only 44 randomized controlled trials and their extension studies. Furthermore, efficacy impacts are not evaluated; only safety is evaluated. FDA regulatory approval for interchangeable biosimilar products is based on demonstrating that neither safety nor treatment efficacy is negatively affected.
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. Thus, according to the ASBM, 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 the Pharmacy Benefit Management Industry Trade Group and the Employee Retirement Income Security Act Industry Committee (representing large, self-insured employers).
I was involved in the drafting of the questioned bill, as mentioned in the press release when Senator Mike Lee (Republican, Utah) introduced it.8 I found that none of the objections from the ASBM hold any merit; however, promoting an opposition by a journal is not what I would consider ethical. This bill should be approved; there is no safety or efficacy risk, only the risk of supporting the views of big pharma companies, as presented by the ASBM and GaBI.
References
1. Schneider PJ, Spiegel A, McKibbin R, Reilly MS. Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health. Generics and Biosimilars Initiative. October 31, 2024. Accessed June 23, 2025. https://www.youtube.com/watch?v=X6-dYZ7fjhM
2. Schneider PJ, Spiegel A, McKibbin R, Reilly MS. Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health. Generics and Biosimilars Initiative. March 25, 2025. Accessed June 23, 2025. https://gabi-journal.net/biosimilar-red-tape-elimination-act-s-2305-weakening-fda-regulatory-standards-for-biosimilars-undermining-physician-confidence-and-jeopardizing-patient-health.html
3. S.2305 - Biosimilar Red Tape Elimination Act. Congress.gov. July 13, 2023. Accessed June 23, 2025. https://www.congress.gov/bill/118th-congress/senate-bill/2305
4. Review and approval. FDA. December 13, 2022. Accessed June 23, 2025. https://www.fda.gov/drugs/biosimilars/review-and-approval
5. Karins J. FDA drug center officials defend biosimilar switching policy change. Inside Health Policy. October 21, 2024. Accessed June 23, 2025. https://insidehealthpolicy.com/daily-news/fda-drug-center-officials-defend-biosimilar-switching-policy-change
6. Reilly MS, McKibbin RD. Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health. GaBi J. 2024;13(2):55-60. doi:10.5639/gabij.2024.1302.009
7. Considerations in demonstrating interchangeability with a reference product. FDA. May 20, 2019. Accessed June 23, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry
8. Lee bill cuts drug prices and red tape. Senator Mike Lee. June 4, 2025. Accessed June 23, 2025. https://www.lee.senate.gov/2025/6/lee-bill-cuts-drug-prices-and-red-tape
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