Biosimilars

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}

Watch Our Video: Biosimilars Explained

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 >

^{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.}