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March 20, 2017

Question of the Day – Monday March 20, 2017

Question: What are “biosimilars”?

Answer:

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm; accessed February 2017)

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  • Education & Groups
    • American Board of Applied Toxicology (ABAT)
      • 2025 ABAT Election Ballot
      • ABAT Travel Grant
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      • Sitting for the American Board of Applied Toxicology Exam
        • ABAT Examination Study Guide
      • Certification Renewal Documents
      • Life Long Learning Articles (LLSA)
      • ABAT Member Directory
        • Diplomate Verification
      • ABAT Board of Directors Contact Information
    • AACT Antidote Collective
    • E-Learning
      • Research Seminar: The Nuts and Bolts of Toxicology Research
      • Advanced Hazmat Life Support Training
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      • ToxNow
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        • COVID Webinar Series
    • Toxicology Residency & Fellowship Training Programs
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