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A biopharmaceutical, also known as a biological medical product,[1] or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, 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. They can be used in both human and animal medicine.[2][3]
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.[4][5][6] Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics.[7][8][9] 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",[10] including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof.[11] 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 biomedicine and biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.[12]
Building on the market approvals and sales of recombinant virus-based biopharmaceuticals for veterinary and human medicine, the use of engineered plant viruses has been proposed to enhance crop performance and promote sustainable production.[13]
In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and medical devices.[14]
- ^ "Biological". Oxford Dictionaries. Archived from the original on October 19, 2019.
- ^ Walsh, Gary (2018). "Biopharmaceutical benchmarks 2018". Nature Biotechnology. 36 (12): 1136–1145. doi:10.1038/nbt.4305. ISSN 1087-0156. PMID 30520869.
- ^ Ryan, Michael P.; Walsh, Gary (2012). "Veterinary-based biopharmaceuticals". Trends in Biotechnology. 30 (12): 615–620. doi:10.1016/j.tibtech.2012.08.005. PMID 22995556.
- ^ Rader RA (July 2008). "(Re)defining biopharmaceutical". Nature Biotechnology. 26 (7): 743–51. doi:10.1038/nbt0708-743. PMID 18612293.
- ^ "Drugs@FDA Glossary of Terms". Food and Drug Administration. 2 Feb 2012. Retrieved 8 April 2014.
- ^ Walsh G (2003). Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition. John Wiley & Sons Ltd. ISBN 978-0-470-84326-0.
- ^ Gleason PP, Alexander GC, Starner CI, Ritter ST, Van Houten HK, Gunderson BW, Shah ND (September 2013). "Health plan utilization and costs of specialty drugs within 4 chronic conditions". Journal of Managed Care Pharmacy. 19 (7): 542–8. doi:10.18553/jmcp.2013.19.7.542. PMC 10437312. PMID 23964615.
- ^ Thomas, Kate; Pollack, Andrew (15 July 2015). "Specialty Pharmacies Proliferate, Along With Questions". New York Times. Sinking Spring, Pa. Retrieved 5 October 2015.
- ^ Murphy CO. "Specialty Pharmacy Managed Care Strategies" (PDF). Retrieved 24 September 2015.
- ^ European Medicines Agency, "tooltip definition of advanced therapy medicinal products", Committee for Advanced Therapies (CAT), retrieved 2017-05-15.
- ^ European Medicines Agency, Advanced therapy medicinal products: Overview, retrieved 2017-05-15.
- ^ Center for Biologics Evaluation and Research (2010-04-01). "What is a biological product?". U.S. Food and Drug Administration. Retrieved 2014-02-09.
- ^ Cite error: The named reference
:0was invoked but never defined (see the help page). - ^ United States Food and Drug Administration (August 2008). "Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule" (PDF). Federal Register. 73 (164): 49603–10. PMID 18958946.
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