What Is a Biosimilar?


1 WHAT IS A BIOSIMILAR? A biosimilar is a biological product FDA-approved biosimilars have been compared to an FDA-approved biologic, wn as the reference product. kno Reference and biosimilar products are: Large and generally Produced from Carefully monitored to living organisms ensure consistent quality complex molecules A biosimilar is highly similar to a reference product For approval, the structure and function of an approved biosimilar o a reference product, were compared t looking at key characteristics such as: Bioactivity Molecular structure Purity The data from these comparisons must show that the biosimilar is highly similar to the reference product. A biosimilar has no clinically meaningful differences from a reference product Studies were performed to show that biosimilars have no clinically es in saf meaningful differenc ety, purity , or potency (safety and effectiveness) Pharmacokinetic Immunogenicity Additional clinical and, if needed, assessment studies as needed compared to the reference product: ph armacodynamic studies Studies may be done independently or combined. A biosimilar is approved by FDA after rigorous evaluation and testing by the applicant Prescribers and patients should have no concerns about using these medications instead of reference products because biosimilars: Are tracked as part Are manufactured Meet FDA’s in FDA-licensed of post-market rigorous standards surveillance to ensure facilities for approval continued safety Visit www.FDA.gov to learn more about biosimilars.

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