Biosimilars
What is a Biosimilar?
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Biosimilars are FDA-approved biologics that have undergone an extensive regulatory evaluation and approval process proving they match the reference medicine in terms of quality, safety and efficacy.1,2
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Confirmatory clinical studies have shown that there is no clinically meaningful difference in terms of safety, purity and potency between biosimilars and their reference biologic.2,3
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Once a biosimilar is approved for one indication, extrapolation based on totality of evidence can allow expansion of its use to other indications for which the reference biologic is approved.2
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In a systematic review of 90 studies on switching from a reference medicine to a biosimilar, which included 7 biosimilars across 14 disease states and 14,225 individuals, the majority of the publications did not report differences in immunogenicity, safety or efficacy.4
See Infographic: Pioneering Biosimilar Access for Patients
Information for Patients
Biological medicines (or “biologics”) are innovative treatments that have transformed the lives of millions of patients with many disabling and life-threatening diseases1. Find out more >
The U.S. Food and Drug Administration released new educational materials for patients related to biosimilars and interchangeable biosimilars – two fact sheets:
Biosimilars What Patients Need to Know,
Biosimilars What Patients with Diabetes Need to Know,
and an infographic: Biosimilar Basics Infographic for Patients.
The materials for patients are also available in Spanish:
Biosimilares: Lo Que los Pacientes Deben Saber,
Biosimilares: Lo Que los Pacientes con Diabetes Deben Saber,
and Conceptos Básicos Sobre los Biosimilares.
References: 1. US Food and Drug Administration. Biosimilar Development, Review, and Approval. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-.... Accessed October 7, 2020. 2. US Department of Health and Human Services. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed October 7, 2020. 3. Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111–5117. 4. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018; 78(4):463-478. 5. US Department of Health and Human Services. Considerations in Demonstrating Interchangeability With a Reference Product: guidance for industry. May 2019. https://www.fda.gov/media/124907/download. Accessed October 7, 2020. 6. Mirazol F. Biosimilars Tackle Interchangeability Standards Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level. Biopharm International. 2020; 33(4), 28–32. 7. 30. US Food and Drug Administration. Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars. March 9. 2020. https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc.... Accessed October 7, 2020.