This is an audio version of the Wikipedia Article:
00:03:08 1 Major classes
00:03:17 1.1 Extracted from living systems
00:04:17 1.2 Produced by recombinant DNA
00:10:02 1.3 Vaccines
00:10:16 1.4 Gene therapy
00:10:36 2 Biosimilars
00:13:18 3 Commercialization
00:15:37 4 Large-scale production
00:16:35 4.1 Transgenics
00:18:16 5 Regulation
00:18:26 5.1 European Union
00:19:58 5.2 United States
00:21:08 6 See also
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A biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial.
Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. 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. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. 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. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.
Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.In some jurisdictions, biologics are regulated via different pathways than other small molecule drugs and medical devices.The term biopharmacology is sometimes used to describe the branch of pharmacology that studies biopharmaceuticals.