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Biologics Definition

Biologics Definition, 42 U.S.C. 262

FDA’s definition of a “Biological Product” (Section 351 PHS Act – as amended by FDAMA): “A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or dondition of human beings.”

Biological products subject to licensure by CBER:

  1. Antitoxins (e.g., Botulism Antitoxin)/Antivenins (e.g., snake, spider)
  2. Immunization Toxoids (e.g., Diphtheria Toxoid, Tetanus Toxoid)
  3. Viral Vaccines (e.g., Rabies, Yellow Fever, Small Pox, Influenza Vaccines)
  4. Blood & Derivatives (e.g., Whole Blood, Red Blood Cells, Albumin, Immune Globulin)
  5. In-Vivo Diagnostic Products (e.g., Tuberculin PPD (skin test)
  6. In-Vitro Diagnostic Products (e.g., Hepatitis B Surface Antigen and Human Immunodeficiency Virus test kits, Reagent Red Blood Cells, Blood Grouping Reagents)
  7. Allergenic Products (e.g., Allergenic Extracts, animal allergens, venoms)
  8. Bacterial Vaccines/Antigens (e.g., Pneumococcal Vaccine, Meningococcal Polysaccharide Vaccine)
  9. Multiple Vaccine/Multiple Antigen Preparations (e.g., Measles, Mumps, Rubella Vaccine; Diptheria, Tetanus, and Pertussis Vaccine)
  10. Biologics & Licensed In-Vivo and In-Vitro Diagnostic Products Not Elsewhere Classified (N.E.C.)

CDER and CBER are responsible for Therapeutic biological products regulated under the FDC Act and/or the PHS Act, as appropriate, include the following:

  1. Monoclonal antibodies for in vivo use.
  2. Most proteins intended for therapeutic use, including cytokines (e.g., interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to the Center for Biologics Evaluation and Research (CBER) (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, humans, or microorganisms, and recombinant versions of these products. Exceptions to this rule are coagulation factors (both recombinant and human-plasma derived).
  3. Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or down-regulating a pre-existing, pathological immune response).
  4. Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo.