Biologic

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Biologics are a wide range of therapies that are derived from biological sources, such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Some biologics are classified as small molecules. However, most biologics developed as a therapy are complex mixtures that are not easily identified or characterized. Examples of complex mixtures include: insulin, Botox (onabotulinumtoxina), Humira (adalimumab), Rituxan (rituximab) and Zolgensma (onasemnogene abeparvovec-xioi).

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U.S. Food and Drug Administration (FDA): What Are “Biologics” Questions and Answers
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NCATS Toolkit for Patient-Focused Therapy Development: Discovery of Therapeutic Approach

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