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What is a Biologic? Biologics or Biological Drugs are disease-modifying drugs produced or sourced from a variety of living organisms such as humans, animals, and microorganisms.
Examples of biologics include vaccines, blood and blood components, cells, tissues, gene therapy, and recombinant proteins.
Biologics are used to treat an array of medical conditions, often offering relief to those who have failed other treatments or for conditions that have no other treatments available. They have been used for the treatment of Cancers, Inflammatory diseases (Psoriasis, Rheumatoid Arthritis, Crohn’s disease), and genetic disorders (Gaucher’s disease).
In contrast to traditional drugs, biologics are less heat stable and more susceptible to contamination, and thus have special guidance for manufacturing from the FDA and are under the purview of the Center for Biologics Evaluation and Research (CBER).
Source: Center for Biologics Evaluation and Research. (2018, February 6). What Are “Biologics” Questions and Answers. U.S. Food and Drug Administration. Retrieved January 25, 2022, from https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers