In their new draft guidance, ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies’, the FDA has proposed updates to simplify biosimilarity studies and reduce unnecessary clinical testing. Additionally, the FDA has plans to simplify processes enabling biosimilars to be developed as interchangeable with originator products.  This means they are substitutable at the pharmacy [1], rather than physician level and lower cost alternatives are more easily accessible to patients. 

The first biosimilar was approved in the US in 2015. However, the FDA highlights that expensive biologicalmedications make up only 5% of US prescriptions but accounted for 51% of total drug expenditure in 2024 [2, 3]. FDA-approved biosimilars only hold a 20% market share. To date, FDA has approved 87 biosimilars [4], but contrastingly there over 30,000 approved generic products [5]. 

The guidance calls for the removal of comparative efficacy studies, that are expensive – costing US$24 million on average, lengthy – taking 1-3 years, and have low sensitivity compared to many other analytical assessments. In their place, developers will be permitted to rely on analytical testing. 

Additionally, at present, developers can be required to perform switching studies for biosimilars to be licensed as interchangeable. These are also lengthy, and the FDA is generally removing this requirement.

This development for biosimilars in the US comes as a direct result of President Trumps Executive Order [6, 7] which seeks to lower drug prices for the American people. In light of this, Health and Human Services Secretary Robert F Kennedy Jr noted, ‘Biologics treat many chronic diseases, but for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars. This bold action by the FDA accelerates biosimilar development, drives market competition, expands patient options, and advances our mission to Make America Healthy Again’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
2. FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs | FDA
3. FACT SHEET: Bringing Lower-Cost Biosimilar Drugs to American Patients | FDA
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
5. Office of Generic Drugs 2022 Annual Report | FDA
6. Lowering Drug Prices by Once Again Putting Americans First – The White House
7. GaBI Online - Generics and Biosimilars Initiative. President Trump issues executive order to lower drug prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us

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