Understanding Biosimilars

Dive deeper into the facts about biosimilars.

What Is a Biosimilar?

A biosimilar is defined as a large, complex molecule that is highly similar to and has no clinically meaningful differences in safety, purity, and potency from the reference product. The FDA affirms that biosimilars are expected to produce the clinical results of the reference product. 1


monoclonal antibody, MAB


Learn the basics about biosimilars

Why Are Biosimilars Important?

In 2009, The Biologics Price Competition and Innovation Act (BPCIA) created a therapeutic approval pathway for biosimilars. This abbreviated pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower healthcare costs through price competition.1,2

How Does the FDA Evaluate Biosimilars?

The streamlined approval process for biosimilars created by the BPCIA includes fewer steps than that of a reference product. This abbreviated pathway does not mean the FDA applies a lower standard to biosimilar products, however. To gain approval, a manufacturer must supply an extensive data package that meets the rigorous standards set by the FDA.1

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FDA Process for Evaluating Biosimilars1,3



See how biosimilars gain FDA approval

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References: 1. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. April 2015. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf . Accessed June 25, 2018. 2. US Food and Drug Administration. Biosimilars. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm. Accessed June 25, 2018. 3. US Food and Drug Administration. Biosimilar Development, Review, and Approval. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm#indication. Accessed June 25, 2018.