![]() ![]() ![]() Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.Īs indicated the term 'biologics' can be used to refer to a wide range of biological products in medicine. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are 'based on genes, cells, or tissue engineering', including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. ![]()
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