What is a Biosimilar?
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
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
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
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.