What Are Biosimilars?

Biosimilars are developed to be highly similar to approved reference products with no clinically meaningful differences in terms of safety, purity, and potency1,2

Reference Product
Graphic depicting  reference IL-6 monoclonal antibody
Graphic depicting  reference IL-6 monoclonal antibody
Graphic depicting  reference IL-6 monoclonal antibody

Adapted from: Brahme, et al. 2021.

Biosimilar Product
Graphic depicting biosimilar IL-6 monoclonal antibody
Graphic depicting biosimilar IL-6 monoclonal antibody
Graphic depicting biosimilar IL-6 monoclonal antibody

Natural within-product variations occur during biosimilar manufacturing: variations are monitored to ensure they fall within an acceptable range2,3

Biologics and biosimilars are large-molecule therapies made through biotechnology in living systems3

Biologics and biosimilars are not exact chemical copies like generics3,4

Biosimilars are biologic therapies that are highly similar to approved biologics, also known as reference products, and have no clinically meaningful differences in terms of safety and efficacy4

694 million

days of patient biosimilar therapy since 2015 as of a September 2023 report5

Estimate: Association Accessible Medicine Report 2023

344 million

incremental days of therapy that would not have occurred without biosimilar competition as of a September 2023 report5

Estimate: Association Accessible Medicine Report 2023

More than 60 biosimilars

approved by the FDA since 2015 as of a February 2025 report6

The first biosimilar was approved in the European Union (EU) in 2006, and the first biosimilar in the US was approved in 20156,7
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FDA=US Food and Drug Administration.

References
  1. Kabir ER, Moreino SS, Sharif Siam MK. The breakthrough of biosimilars: a twist in the narrative of biological therapy. Biomolecules. 2019;9(9):410.
  2. Brahme N, Hann L, Ikenberry S. FDA drug topics. Biosimilar and interchangeable biological products: basic concepts and practical resources. US Food and Drug Administration. https://www.fda.gov/media/145163/download. Accessed September 2024.
  3. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28(4):363-372.
  4. US Food and Drug Administration. Biosimilar basics for patients. October 26, 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients. Accessed September 2024.
  5. Association for Accessible Medicines. The US generic & biosimilar medicines savings report. September 2023. https://accessiblemeds.org/wp-content/uploads/2024/11/AAM-2023-Generic-Biosimilar-Medicines-Savings-Report-web.pdf. Accessed September 2024.
  6. US Food and Drug Administration. Biosimilar product information. February 14, 2025. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed February 2025.
  7. European Medicines Agency. Biosimilars in the EU: information guide for healthcare professionals. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed September 2024.