The US Department of Health and Human Services (HHS), through the US Food and Drug Administration’s (FDA), is launching an initiative to ‘genericize’ biosimilars. Fast-tracking approvals and eliminating key clinical and switching studies represent a radical departure from established global regulatory science.
A recent opinion piece by members of the Alliance for Safe Biologic Medicines (ASBM), published in GaBI Journal [1], explores this shift which discards two decades of scientific consensus.
Announced by HHS Secretary Robert F Kennedy Jr and then-FDA Commissioner Dr Marty Makary, this fast-tracking of biosimilar approvals has ignited controversy among regulators, physicians, and global health policy experts. Dr Makary officially resigned as FDA Commissioner on 12 May 2026.
Major global authorities, including the European Medicines Agency (EMA), Health Canada, Australia’s Therapeutic Goods Administration (TGA), the World Health Organization (WHO), and historically, the FDA, explicitly state that biosimilars are not generics and require distinct regulatory pathways.
Kennedy framed the move by alleging that industry invented a distinction between biosimilars and interchangeable biosimilars to prevent pharmacists from substituting lower-cost products. Dr Makary has suggested most biosimilars could be approved primarily on analytical data, with comparative clinical trials largely eliminated and all products deemed ‘interchangeable’, enabling automatic pharmacy substitution.
Since the first biosimilar approvals in the mid-2000s, regulators worldwide have adopted a ‘totality of evidence’ framework requiring stepwise demonstration of similarity, including structural, functional and, when necessary, clinical comparisons. Biological medicines are derived from living systems and cannot be fully characterized through chemistry alone, meaning small differences in structure or manufacturing may have clinical implications.
Supporters describe the changes as overdue modernization. But critics warn they amount to a ‘genericization’ of biosimilars, collapsing the long-standing scientific and legal distinction between biologicalmedicines and small-molecule generics.
In the US, the legal framework stems from the Biologics Price Competition and Innovation Act (BPCI Act). Under this law, biosimilars must show no clinically meaningful differences from a reference product at the population level. A separate ‘interchangeable’ designation allows automatic pharmacy substitution but requires additional evidence demonstrating that switching poses no added risk to individual patients.
Kennedy has characterized this distinction as unnecessary. However, the interchangeable standard was built into federal law and later reinforced by state pharmacy legislation, with assurances to clinicians and patients that third-party substitution would be supported by appropriate data.
Physician surveys suggest limited appetite for eliminating that safeguard. Recent polling of US biologicalprescribers found only a small minority favour treating all biosimilars as interchangeable by default, while most support case-by-case FDA evaluation and say switching studies increase confidence.
European experience echoes that caution. Although biosimilars are widely used for new patients, many EU countries restrict or prohibit automatic pharmacy-level substitution without prescriber involvement.
Critics argue the main barrier to US biosimilar uptake is not FDA standards but formulary decisions by pharmacy benefit managers (PBMs) and insurers [2, 3]. For example, despite 10 FDA-approved Humira biosimilars, eight designated as interchangeable, the originator retains roughly 80% market share, largely due to rebate-driven contracting and formulary placement [4].
Biosimilars have generated more than US$50 billion in US savings, with deeper discounts emerging as competition grows. Analysts warn that lowering approval standards would not reform rebate structures or ensure savings reach patients, but could instead expand insurers’ ability to mandate switches for financial reasons.
While some industry groups support streamlining requirements, critics caution that eliminating clinical confirmation and granting blanket interchangeability could erode physician trust and destabilize patients with well-controlled disease.
The authors warn that, for two decades, regulators have built a biosimilar framework balancing competition with patient safety. Whether the HHS initiative represents pragmatic reform or a break from that model may shape biological medicine regulation in the US and beyond.
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References
1. Reilly MS, Schneider PJ, Spiegel A. Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are? Generics and Biosimilars Initiative Journal (GaBI Journal). 2026;15(1).22-6. doi:10.5639/gabij.2026.1501.004
2. GaBI Online - Generics and Biosimilars Initiative. FTC reveals extent of PBM drug mark-ups and profits [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from:
www.gabionline.net/reports/ftc-reveals-extent-of-pbm-drug-mark-ups-and-profits
3. GaBI Online - Generics and Biosimilars Initiative. Federal intervention, Direct-to-Consumer pricing, and PBM reform reshape US 2026 drug pricing [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/pharma-news/federal-intervention-direct-to-consumer-pricing-and-pbm-reform-reshape-us-2026-drug-pricing
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/pharma-news/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US
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