Biologic Definition — SCE Rheumatology MCQ
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Correct answer: E — A medicine whose active substance is derived from a biological living source
Option E is correct. A biological medicine is defined principally by its derivation from a biological living source, such as microorganisms, blood, tissues or cultured cells. Many biological medicines used in rheumatology are large recombinant proteins, including monoclonal antibodies and fusion proteins, but this is not the complete technical definition: the wider category also includes vaccines, insulin and coagulation factors. Novelty, acquisition cost and route of administration do not determine whether a medicine is biological. Although many rheumatology biologics are injected or infused, injection alone does not make a drug biological. Monoclonal antibodies are an important subclass rather than the whole category.
Reference: Medicines and Healthcare products Regulatory Agency. Standards for biological medicines — understanding them and how they make a difference, section ‘What is a biological medicine?’, 2017. https://www.gov.uk/government/news/standards-for-biological-medicines-understanding-them-and-how-they-make-a-difference