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Biologic Classification

Meaning

The systematic organization and categorization of biological products based on their source, structure, and mechanism of action for regulatory and clinical purposes. Biologics are complex therapeutic substances derived from living organisms, including cells, tissues, proteins, and vaccines, contrasting with small-molecule drugs synthesized chemically. Classification schemes differentiate products by their complexity, manufacturing process, and regulatory pathway, which is essential for ensuring product consistency and patient safety. This framework dictates the specific non-clinical and clinical data required for regulatory approval and subsequent clinical use.