1038:
and by 2001 there were 34,527 patent applications. In 2012 the US had the highest IP (Intellectual
Property) generation within the biopharmaceutical industry, generating 37 percent of the total number of granted patents worldwide; however, there is still a large margin for growth and innovation within the industry. Revisions to the current IP system to ensure greater reliability for R&D (research and development) investments is a prominent topic of debate in the US as well. Blood products and other human-derived biologics such as breast milk have highly regulated or very hard-to-access markets; therefore, customers generally face a supply shortage for these products. Institutions housing these biologics, designated as 'banks', often cannot distribute their product to customers effectively. Conversely, banks for reproductive cells are much more widespread and available due to the ease with which
377:, and others. In most of these disciplines, biologics have added major therapeutic options for treating many diseases, including some for which no effective therapies were available, and others where previously existing therapies were inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are used to treat
1055:
2488:
2987:
981:, biologics are vastly more complex and consist of a multitude of subspecies. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. Process variations are monitored by modern analytical tools (e.g.,
211:
1164:, a biological medicinal product is one of the active substance(s) produced from or extracted from a biological (living) system, and requires, in addition to physicochemical testing, biological testing for full characterisation. The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with the production process and its control. For example:
2999:
381:, such as rheumatoid arthritis or inflammatory bowel disease, or for the treatment of otherwise untreatable cancer during the remainder of life. The cost of treatment with a typical monoclonal antibody therapy for relatively common indications is generally in the range of €7,000–14,000 per patient per year.
1012:
of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. Researchers are optimistic that the introduction of biosimilars will reduce medical expenses to patients and the healthcare system.
1126:
to produce drugs. This production is a significant risk for its investor due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for
1037:
differ somewhat on the requirements for a patent, with the
European requirements perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995,
996:
Biosimilars require a different regulatory framework compared to small-molecule generics. Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing
1223:, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a
333:
technology or other methods) and can therefore be made specifically to counteract or block any given substance in the body, or to target any specific cell type; examples of such monoclonal antibodies for use in various diseases are given in the table
176:(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
194:
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.
302:
can refer to a wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving
1134:
method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome. The first such drug manufactured from the milk of a genetically modified
2299:
124:
Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some
1130:
One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine. Once an animal is produced, typically using the
2326:
1025:, which is a grant to exclusive manufacturing rights. This is the primary means by which the drug developer can recover the investment cost for development of the biopharmaceutical. The
2064:
345:
frame. In this case, the receptor provides the construct with detailed specificity, whereas the immunoglobulin structure imparts stability and other useful features in terms of
2278:"Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use"
2972:
1168:
Production process – it can be derived from biotechnology or from other technologies. It may be prepared using more conventional techniques as is the case for blood or
1977:
512:
Research and development investment in new medicines by the biopharmaceutical industry stood at $ 65.2 billion in 2008. A few examples of biologics made with
2091:
1577:
1008:. This pathway is based on a thorough demonstration of comparability of the product to an existing approved product. Within the United States, the
329:. These are similar to the antibodies that the human immune system uses to fight off bacteria and viruses, but they are "custom-designed" (using
2404:
148:, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.
1227:
environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug.
1678:
Pasin, Fabio; Uranga, Mireia; Charudattan, Raghavan; Kwon, Choon-Tak (2024-05-15). "Engineering good viruses to improve crop performance".
1212:
226:
Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include:
1550:
1767:
2039:
1009:
951:
Viral gene therapies using engineered plant viruses have been proposed to enhance crop performance and promote sustainable production.
2277:
1631:
1088:. Important issues of concern are cost of production (low-volume, high-purity products are desirable) and microbial contamination (by
2477:
905:
311:
Substances that are (nearly) identical to the body's key signaling proteins. Examples are the blood-production stimulating protein
2444:
2141:
Decker EL, Reski R (January 2008). "Current achievements in the production of complex biopharmaceuticals with moss bioreactors".
1216:
1605:
2653:
2360:
1484:
1298:
1984:
353:
Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily
1211:, biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's
1711:"Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule"
526:
1744:
973:
between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. Compared to
3045:
1268:
1239:, biologics (and radiopharmaceuticals) are reviewed through the Biologics and Genetic Therapies Directorate within
3040:
3030:
2962:
2684:
294:
3003:
2967:
281:
Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by
17:
2811:
2578:
1453:
1273:
445:
198:
In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and
3025:
2801:
2437:
839:
608:
275:
1500:
Gleason PP, Alexander GC, Starner CI, Ritter ST, Van Houten HK, Gunderson BW, Shah ND (September 2013).
191:, and may be used to treat a variety of medical conditions for which no other treatments are available.
121:
sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
2658:
2017:
1101:
522:
2472:
2228:
1887:
Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M (April 2018).
1710:
1627:
1601:
1144:
1001:
466:
169:
1131:
3055:
2828:
2507:
2467:
2408:
2352:
1191:
1026:
2724:
2502:
1654:
1449:
1370:
1253:
113:, or complex combinations of these substances, or may be living cells or tissues. They (or their
168:, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The
3035:
2991:
2896:
2881:
2709:
2603:
2583:
2430:
2348:
901:
825:
586:
505:
393:
180:
refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.
1147:
in
February 2006. This decision was reversed in June 2006 and approval was given August 2006.
1771:
982:
656:
423:
236:
114:
2043:
2921:
2784:
2648:
2598:
2386:
1073:
817:
553:
385:
90:
2301:
Key
Regulatory Guidelines for the Development of Biologics in the United States and Europe
8:
2806:
2789:
2769:
2749:
1258:
1123:
1113:
897:
842:
834:
821:
787:
752:
662:
611:
603:
590:
498:
396:
are at increased risk for life-threatening infection, adverse cardiovascular events, and
389:
326:
264:
188:
50:
31:
2251:
1526:
1501:
2816:
2562:
2209:
2166:
2011:
1978:"Questions and answers on biosimilar medicines (similar biological medicinal products)"
1952:
1823:
1796:
978:
941:
861:
857:
829:
769:
764:
760:
730:
704:
700:
598:
594:
3050:
2941:
2936:
2714:
2588:
2201:
2158:
1932:
1910:
1869:
1828:
1725:
1691:
1531:
1480:
1431:
1390:
1351:
1343:
1263:
1085:
990:
245:
240:
125:
2213:
1956:
1768:"Biopharmaceutical sector sees rising R&D despite credit crunch, finds analysis"
1100:). Alternative platforms of production which are being tested include whole plants (
2871:
2838:
2593:
2367:
2193:
2170:
2150:
2008:
1944:
1900:
1859:
1818:
1808:
1683:
1521:
1513:
1421:
1382:
1333:
1063:
970:
893:
378:
370:
254:
86:
1905:
1888:
1502:"Health plan utilization and costs of specialty drugs within 4 chronic conditions"
1386:
1306:
1021:
When a new biopharmaceutical is developed, the company will typically apply for a
2704:
2699:
2689:
974:
798:
Diphtheria toxin engineered protein combining
Interleukin-2 and Diphtheria toxin
513:
408:
304:
282:
165:
94:
62:
2387:"Report for USA Specialty Pharmaceuticals: Generic Biologics: The Next Frontier"
1517:
2876:
2853:
2759:
2754:
2694:
2679:
2643:
2528:
1889:"Maintaining consistent quality and clinical performance of biopharmaceuticals"
1687:
1220:
1184:
1161:
779:
775:
640:
564:
462:
403:
The first such substance approved for therapeutic use was biosynthetic "human"
342:
338:
316:
199:
2154:
699:
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis,
183:
Gene-based and cellular biologics, for example, often are at the forefront of
3019:
2774:
2729:
2638:
2453:
1848:"Acceptable changes in quality attributes of glycosylated biopharmaceuticals"
1846:
Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R (April 2011).
1695:
1347:
1240:
1208:
1180:
1176:
1030:
801:
725:
680:
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis
312:
153:
137:
54:
1797:"Biosimilars: company strategies to capture value from the biologics market"
1652:
1118:
A potentially controversial method of producing biopharmaceuticals involves
2926:
2911:
2823:
2764:
2663:
2633:
2542:
2205:
2162:
2117:
1914:
1873:
1832:
1729:
1535:
1435:
1394:
1355:
1278:
1195:
1169:
1069:
1062:
Biopharmaceuticals may be produced from microbial cells (e.g., recombinant
1039:
652:
558:
354:
346:
214:
161:
141:
110:
98:
82:
78:
2275:
2040:"Patenting in the Biopharmaceutical Industry—comparing the US with Europe"
2015:
1708:
2916:
2906:
2901:
2018:"Approval Pathway for Biosimilar and Interchangeable Biological Products"
986:
849:
744:
717:
488:
478:
434:
366:
270:
230:
184:
70:
2487:
1426:
1409:
1187:
components originating from a microbial, animal, human, or plant source.
1054:
2843:
2796:
2719:
2628:
1948:
1119:
1097:
1081:
960:
885:
691:
672:
577:
472:
412:
397:
362:
74:
1813:
217:
is a type of biopharmaceutical directly extracted from living systems.
1864:
1847:
1338:
1321:
1224:
809:
756:
627:
618:
545:
438:
419:
374:
330:
210:
2946:
2848:
2229:"European Regulators Curdle Plans for Goat Milk Human Antithrombin"
1190:
Mode of action – therapeutic and immunological medicinal products,
1089:
1043:
877:
736:
358:
250:
2197:
1477:
Biopharmaceuticals: Biochemistry and
Biotechnology, Second Edition
2886:
2779:
2557:
2552:
966:
928:
492:
484:
455:
451:
415:
404:
384:
Older patients who receive biologic therapy for diseases such as
341:), usually based on a naturally occurring receptor linked to the
320:
106:
66:
58:
2422:
1845:
2931:
2523:
2096:
1933:"The US Biosimilars Act: Challenges Facing Regulatory Approval"
1604:, "tooltip definition of advanced therapy medicinal products",
1236:
1034:
1022:
648:
569:
561:
1794:
993:, etc.) and describe a unique design space for each biologic.
307:
technology. These medications are usually one of three types:
2973:
List of largest biomedical companies by market capitalization
2833:
1499:
1140:
1093:
945:
913:
258:
102:
2547:
2407:. National Psoriasis Foundation. 2006-11-01. Archived from
2366:. Biotechnology Industry Organization (BIO). Archived from
1653:
Center for
Biologics Evaluation and Research (2010-04-01).
1548:
1136:
1077:
145:
118:
1709:
1677:
1122:
organisms, particularly plants and animals that have been
2537:
2533:
2276:
The
Commission of the European Communities (2003-06-25).
2065:"Growth and Policies Behind Biopharmaceutical Innovation"
2016:
2384:
2184:
Dove A (October 2000). "Milking the genome for profit".
1745:"The use of biologic agents in the geriatric population"
1551:"Specialty Pharmacies Proliferate, Along With Questions"
2031:
1886:
1795:
Calo-Fernández B, MartĂnez-Hurtado JL (December 2012).
1004:
introduced an adapted pathway for biosimilars, termed
1626:
1600:
1542:
426:, who manufactured and marketed it starting in 1982.
2297:
1926:
1924:
997:than for registering completely new therapeutics.
948:to include a desirable piece of genetic material.
2358:
30:"Biologics" redirects here. For the journal, see
3017:
1058:Stainless steel bioreactor for production plants
221:
2269:
2226:
1921:
2001:
1790:
1788:
1765:
1549:Thomas, Kate; Pollack, Andrew (15 July 2015).
1143:, but marketing permission was blocked by the
1068:or yeast cultures), mammalian cell lines (see
683:recombinant human TNF-receptor fusion protein
349:. Some examples are listed in the table below.
288:
2438:
2327:"Biologics and Genetic Therapies Directorate"
1633:Advanced therapy medicinal products: Overview
2307:. John Wiley & Sons, Inc. pp. 75–88
2177:
2134:
1839:
1702:
1578:"Specialty Pharmacy Managed Care Strategies"
1213:Center for Biologics Evaluation and Research
933:Many vaccines are grown in tissue cultures.
53:product manufactured in, extracted from, or
2140:
1983:. European Medicines Agency. Archived from
1785:
1401:
1172:-derived products and a number of vaccines.
458:, glucagon, growth hormone, gonadotrophins)
429:Major kinds of biopharmaceuticals include:
315:, or the growth-stimulating hormone named "
2445:
2431:
2092:"The Guys Who Trade Your Blood For Profit"
1215:(CBER) whereas drugs are regulated by the
1010:Patient Protection and Affordable Care Act
411:. Sometimes referred to as rHI, under the
2385:Timothy B. Coan; Ron Ellis (2001-06-01).
2351:at the U.S. National Library of Medicine
1904:
1863:
1822:
1812:
1620:
1525:
1425:
1368:
1337:
1049:
667:stimulation of red blood cell production
2478:Competitions and prizes in biotechnology
1493:
1219:. Approval may require several years of
1175:Active substance – consisting of entire
1053:
906:non-radiographic axial spondyloarthritis
209:
2118:"Sperm Donors Australia | Donate Sperm"
1646:
1594:
1217:Center for Drug Evaluation and Research
14:
3018:
2285:Official Journal of the European Union
1607:Committee for Advanced Therapies (CAT)
1369:Ryan, Michael P.; Walsh, Gary (2012).
2426:
2298:Kingham R, Klasa G, Carver K (2014).
2143:Bioprocess and Biosystems Engineering
1673:
1671:
1474:
1407:
1371:"Veterinary-based biopharmaceuticals"
1319:
1084:of various configurations, including
1046:can be used for fertility treatment.
1006:similar biological medicinal products
977:that consist of chemically identical
944:involves artificially manipulating a
2998:
2183:
2025:Public Hearing; Request for Comments
1969:
1930:
1893:Expert Opinion on Biological Therapy
1742:
1016:
156:that works with biopharmaceuticals.
136:to refer specifically to engineered
2089:
1975:
1657:. U.S. Food and Drug Administration
1569:
1322:"Biopharmaceutical benchmarks 2018"
174:advanced therapy medicinal products
24:
2252:"Go-ahead for 'pharmed' goat drug"
2037:
1668:
1575:
1179:, mammalian cells, nucleic acids,
25:
3067:
2452:
2342:
1155:
795:cutaneous T-cell lymphoma (CTCL)
164:that studies biopharmaceuticals.
117:or components) are isolated from
2997:
2986:
2985:
2486:
2392:. Consumer Project on Technology
1506:Journal of Managed Care Pharmacy
1410:"(Re)defining biopharmaceutical"
1269:List of pharmaceutical companies
1202:
205:
27:Drug made from biological source
2963:Index of biotechnology articles
2319:
2291:
2244:
2220:
2110:
2083:
2057:
1880:
1759:
1736:
1655:"What is a biological product?"
1072:) and plant cell cultures (see
936:
632:immunoglobin G1 fusion protein
481:-based products (Interleukin-2)
461:Haematopoietic growth factors (
295:Biologics for immunosuppression
101:. Biologics can be composed of
91:recombinant therapeutic protein
2968:List of biotechnology articles
1468:
1442:
1362:
1313:
1291:
1107:
954:
910:humanized monoclonal antibody
134:therapeutic biological product
65:pharmaceuticals, they include
13:
1:
2812:Genetically modified organism
2579:Biotechnology industrial park
1906:10.1080/14712598.2018.1421169
1680:Nature Reviews Bioengineering
1479:. John Wiley & Sons Ltd.
1450:"Drugs@FDA Glossary of Terms"
1387:10.1016/j.tibtech.2012.08.005
1285:
1150:
222:Extracted from living systems
130:biological medicinal products
1454:Food and Drug Administration
1274:List of recombinant proteins
965:With the expiration of many
446:tissue plasminogen activator
7:
2802:Environmental biotechnology
2122:spermdonorsaustralia.com.au
1518:10.18553/jmcp.2013.19.7.542
1246:
922:
635:incompletely characterized
289:Produced by recombinant DNA
140:products like protein- and
10:
3072:
2359:Debbie Strickland (2007).
1688:10.1038/s44222-024-00197-y
1111:
1102:plant-made pharmaceuticals
958:
926:
467:colony-stimulating factors
292:
233:and other blood components
43:biological medical product
29:
2981:
2955:
2862:
2742:
2672:
2621:
2612:
2571:
2516:
2495:
2484:
2473:Timeline of biotechnology
2460:
2155:10.1007/s00449-007-0151-y
1628:European Medicines Agency
1602:European Medicines Agency
1230:
1145:European Medicines Agency
1132:pronuclear microinjection
1002:European Medicines Agency
170:European Medicines Agency
2829:Microbial biodegradation
2508:Industrial biotechnology
2468:History of biotechnology
2361:"Guide to Biotechnology"
2353:Medical Subject Headings
319:" or biosynthetic human
265:Human reproductive cells
61:sources. Different from
3046:Pharmaceutical industry
2503:Colors of biotechnology
1375:Trends in Biotechnology
1254:Antibody-drug conjugate
475:(Interferons-α, -β, -γ)
3041:Life sciences industry
3031:Biotechnology products
2897:Biomedical engineering
2604:Pharmaceutical company
2584:Biotechnology products
1408:Rader RA (July 2008).
1127:non-medical purposes.
1059:
1050:Large-scale production
902:ankylosing spondylitis
826:ankylosing spondylitis
587:ankylosing spondylitis
585:rheumatoid arthritis,
508:, therapeutic enzymes)
506:tumour necrosis factor
394:ankylosing spondylitis
218:
2227:Phillip B. C. Jones.
1057:
983:liquid chromatography
971:blockbuster biologics
657:chronic renal failure
504:Additional products (
499:Monoclonal antibodies
444:Thrombolytic agents (
424:Eli Lilly and Company
337:Receptor constructs (
327:Monoclonal antibodies
237:Organ transplantation
213:
2922:Chemical engineering
2785:Reproductive cloning
2649:Hybridoma technology
2599:Human Genome Project
2186:Nature Biotechnology
1852:Nature Biotechnology
1766:BriskFox Financial.
1557:. Sinking Spring, Pa
1414:Nature Biotechnology
1326:Nature Biotechnology
1320:Walsh, Gary (2018).
1309:on October 19, 2019.
1124:genetically modified
1074:Plant tissue culture
866:monoclonal antibody
818:rheumatoid arthritis
772:monoclonal antibody
733:monoclonal antibody
709:monoclonal antibody
651:arising from cancer
554:rheumatoid arthritis
540:Mechanism of action
516:technology include:
386:rheumatoid arthritis
73:, blood components,
2807:Genetic engineering
2790:Therapeutic cloning
2770:Bionic architecture
2750:Animal cell culture
2517:Biological concepts
2349:Biological Products
2287:. p. L 159/62.
1427:10.1038/nbt0708-743
1303:Oxford Dictionaries
1259:Genetic engineering
1114:Pharming (genetics)
898:psoriatic arthritis
835:monoclonal antibody
822:psoriatic arthritis
788:denileukin diftitox
753:psoriatic arthritis
739:(erbB2) antagonist
663:recombinant protein
604:monoclonal antibody
591:psoriatic arthritis
418:, was developed by
390:psoriatic arthritis
189:biomedical research
126:regulatory agencies
63:totally synthesized
51:pharmaceutical drug
32:Biologics (journal)
3026:Biopharmaceuticals
2863:Interdisciplinary
2817:Molecular genetics
2563:Selective breeding
1976:EMA (2008-10-30).
1949:10.1007/bf03262388
1060:
979:active ingredients
942:Viral gene therapy
858:ulcerative colitis
830:ulcerative colitis
761:ulcerative colitis
701:ulcerative colitis
595:ulcerative colitis
422:, but licensed to
323:and its analogues.
257:(e.g., to treat a
241:tissue transplants
219:
178:advanced therapies
41:, also known as a
3013:
3012:
2942:Nanobiotechnology
2937:Molecular biology
2738:
2737:
2589:Biotechnology law
2405:"About biologics"
1814:10.3390/ph5121393
1749:J Musculoskel Med
1724:(164): 49603–10.
1486:978-0-470-84326-0
1332:(12): 1136–1145.
1264:Host cell protein
1086:photo-bioreactors
1017:Commercialization
991:mass spectrometry
920:
919:
246:Stem-cell therapy
160:is the branch of
39:biopharmaceutical
16:(Redirected from
3063:
3001:
3000:
2989:
2988:
2839:Pharmacogenomics
2619:
2618:
2613:Basic techniques
2594:Green Revolution
2572:General concepts
2490:
2447:
2440:
2433:
2424:
2423:
2419:
2417:
2416:
2400:
2398:
2397:
2391:
2381:
2379:
2378:
2372:
2365:
2337:
2336:
2334:
2333:
2323:
2317:
2316:
2314:
2312:
2306:
2295:
2289:
2288:
2282:
2273:
2267:
2266:
2264:
2263:
2248:
2242:
2241:
2239:
2238:
2233:
2224:
2218:
2217:
2181:
2175:
2174:
2138:
2132:
2131:
2129:
2128:
2114:
2108:
2107:
2105:
2104:
2087:
2081:
2080:
2078:
2076:
2061:
2055:
2054:
2052:
2051:
2042:. Archived from
2035:
2029:
2028:
2022:
2005:
1999:
1998:
1996:
1995:
1989:
1982:
1973:
1967:
1966:
1964:
1963:
1928:
1919:
1918:
1908:
1884:
1878:
1877:
1867:
1865:10.1038/nbt.1839
1843:
1837:
1836:
1826:
1816:
1807:(12): 1393–408.
1792:
1783:
1782:
1780:
1779:
1770:. Archived from
1763:
1757:
1756:
1743:Kerr LD (2010).
1740:
1734:
1733:
1718:Federal Register
1715:
1706:
1700:
1699:
1675:
1666:
1665:
1663:
1662:
1650:
1644:
1643:
1641:
1640:
1624:
1618:
1617:
1615:
1614:
1598:
1592:
1591:
1589:
1587:
1582:
1573:
1567:
1566:
1564:
1562:
1546:
1540:
1539:
1529:
1497:
1491:
1490:
1475:Walsh G (2003).
1472:
1466:
1465:
1463:
1461:
1446:
1440:
1439:
1429:
1405:
1399:
1398:
1366:
1360:
1359:
1341:
1339:10.1038/nbt.4305
1317:
1311:
1310:
1305:. Archived from
1295:
894:plaque psoriasis
804:receptor binder
519:
518:
379:chronic diseases
371:gastroenterology
276:Fecal microbiota
255:passive immunity
150:Biopharmaceutics
95:living medicines
21:
3071:
3070:
3066:
3065:
3064:
3062:
3061:
3060:
3056:Specialty drugs
3016:
3015:
3014:
3009:
2977:
2951:
2892:Biopharmacology
2864:
2858:
2734:
2705:Electrophoresis
2700:Kidney dialysis
2690:Crystallization
2668:
2614:
2608:
2567:
2512:
2491:
2482:
2456:
2451:
2414:
2412:
2403:
2395:
2393:
2389:
2376:
2374:
2370:
2363:
2345:
2340:
2331:
2329:
2325:
2324:
2320:
2310:
2308:
2304:
2296:
2292:
2280:
2274:
2270:
2261:
2259:
2250:
2249:
2245:
2236:
2234:
2231:
2225:
2221:
2182:
2178:
2139:
2135:
2126:
2124:
2116:
2115:
2111:
2102:
2100:
2090:Carlyle, Erin.
2088:
2084:
2074:
2072:
2063:
2062:
2058:
2049:
2047:
2036:
2032:
2020:
2006:
2002:
1993:
1991:
1987:
1980:
1974:
1970:
1961:
1959:
1931:Nick C (2012).
1929:
1922:
1885:
1881:
1844:
1840:
1801:Pharmaceuticals
1793:
1786:
1777:
1775:
1764:
1760:
1741:
1737:
1713:
1707:
1703:
1676:
1669:
1660:
1658:
1651:
1647:
1638:
1636:
1625:
1621:
1612:
1610:
1599:
1595:
1585:
1583:
1580:
1574:
1570:
1560:
1558:
1547:
1543:
1498:
1494:
1487:
1473:
1469:
1459:
1457:
1448:
1447:
1443:
1406:
1402:
1381:(12): 615–620.
1367:
1363:
1318:
1314:
1297:
1296:
1292:
1288:
1283:
1249:
1233:
1221:clinical trials
1205:
1158:
1153:
1116:
1110:
1052:
1019:
975:small molecules
963:
957:
939:
931:
925:
876:
872:
862:Crohn's disease
765:Crohn's disease
712:TNF antagonist
705:Crohn's disease
686:TNF antagonist
626:chronic plaque
599:Crohn's disease
514:recombinant DNA
433:Blood factors (
409:recombinant DNA
339:fusion proteins
305:recombinant DNA
297:
291:
283:recombinant DNA
224:
208:
200:medical devices
166:Specialty drugs
158:Biopharmacology
55:semisynthesized
35:
28:
23:
22:
15:
12:
11:
5:
3069:
3059:
3058:
3053:
3048:
3043:
3038:
3033:
3028:
3011:
3010:
3008:
3007:
2995:
2982:
2979:
2978:
2976:
2975:
2970:
2965:
2959:
2957:
2953:
2952:
2950:
2949:
2944:
2939:
2934:
2929:
2924:
2919:
2914:
2909:
2904:
2899:
2894:
2889:
2884:
2882:Bioengineering
2879:
2877:Bioelectronics
2874:
2868:
2866:
2860:
2859:
2857:
2856:
2854:Tissue culture
2851:
2846:
2841:
2836:
2831:
2826:
2821:
2820:
2819:
2814:
2804:
2799:
2794:
2793:
2792:
2787:
2777:
2772:
2767:
2762:
2760:Bioinformatics
2757:
2755:Biofabrication
2752:
2746:
2744:
2740:
2739:
2736:
2735:
2733:
2732:
2727:
2722:
2717:
2712:
2707:
2702:
2697:
2695:Chromatography
2692:
2687:
2682:
2680:Centrifugation
2676:
2674:
2673:Chemical field
2670:
2669:
2667:
2666:
2661:
2656:
2651:
2646:
2644:Flow cytometry
2641:
2636:
2631:
2625:
2623:
2616:
2610:
2609:
2607:
2606:
2601:
2596:
2591:
2586:
2581:
2575:
2573:
2569:
2568:
2566:
2565:
2560:
2555:
2550:
2545:
2540:
2531:
2526:
2520:
2518:
2514:
2513:
2511:
2510:
2505:
2499:
2497:
2493:
2492:
2485:
2483:
2481:
2480:
2475:
2470:
2464:
2462:
2458:
2457:
2450:
2449:
2442:
2435:
2427:
2421:
2420:
2401:
2382:
2356:
2344:
2343:External links
2341:
2339:
2338:
2318:
2290:
2268:
2243:
2219:
2192:(10): 1045–8.
2176:
2133:
2109:
2082:
2056:
2038:Foster, Luke.
2030:
2000:
1968:
1943:(3): 145–152.
1920:
1899:(4): 369–379.
1879:
1838:
1784:
1758:
1735:
1701:
1667:
1645:
1619:
1593:
1568:
1555:New York Times
1541:
1492:
1485:
1467:
1441:
1400:
1361:
1312:
1289:
1287:
1284:
1282:
1281:
1276:
1271:
1266:
1261:
1256:
1250:
1248:
1245:
1232:
1229:
1204:
1201:
1200:
1199:
1194:materials, or
1188:
1185:polysaccharide
1177:microorganisms
1173:
1162:European Union
1157:
1156:European Union
1154:
1152:
1149:
1112:Main article:
1109:
1106:
1051:
1048:
1018:
1015:
959:Main article:
956:
953:
938:
935:
927:Main article:
924:
921:
918:
917:
911:
908:
891:
888:
882:
881:
874:
870:
867:
864:
855:
852:
846:
845:
837:
832:
815:
812:
806:
805:
799:
796:
793:
790:
784:
783:
773:
767:
750:
747:
741:
740:
734:
728:
723:
720:
714:
713:
710:
707:
697:
694:
688:
687:
684:
681:
678:
675:
669:
668:
665:
660:
646:
643:
641:erythropoietin
637:
636:
633:
630:
624:
621:
615:
614:
606:
601:
583:
580:
574:
573:
567:
565:fusion protein
556:
551:
548:
542:
541:
538:
535:
532:
529:
510:
509:
502:
496:
482:
476:
470:
463:Erythropoietin
459:
449:
442:
351:
350:
343:immunoglobulin
335:
324:
317:growth hormone
290:
287:
279:
278:
273:
267:
262:
248:
243:
234:
223:
220:
207:
204:
172:uses the term
138:macromolecular
128:use the terms
83:gene therapies
26:
18:Biotherapeutic
9:
6:
4:
3:
2:
3068:
3057:
3054:
3052:
3049:
3047:
3044:
3042:
3039:
3037:
3036:Biotechnology
3034:
3032:
3029:
3027:
3024:
3023:
3021:
3006:
3005:
2996:
2994:
2993:
2984:
2983:
2980:
2974:
2971:
2969:
2966:
2964:
2961:
2960:
2958:
2954:
2948:
2945:
2943:
2940:
2938:
2935:
2933:
2930:
2928:
2925:
2923:
2920:
2918:
2915:
2913:
2910:
2908:
2905:
2903:
2900:
2898:
2895:
2893:
2890:
2888:
2885:
2883:
2880:
2878:
2875:
2873:
2870:
2869:
2867:
2861:
2855:
2852:
2850:
2847:
2845:
2842:
2840:
2837:
2835:
2832:
2830:
2827:
2825:
2822:
2818:
2815:
2813:
2810:
2809:
2808:
2805:
2803:
2800:
2798:
2795:
2791:
2788:
2786:
2783:
2782:
2781:
2778:
2776:
2775:Cell immunity
2773:
2771:
2768:
2766:
2763:
2761:
2758:
2756:
2753:
2751:
2748:
2747:
2745:
2741:
2731:
2730:Sedimentation
2728:
2726:
2723:
2721:
2718:
2716:
2713:
2711:
2708:
2706:
2703:
2701:
2698:
2696:
2693:
2691:
2688:
2686:
2683:
2681:
2678:
2677:
2675:
2671:
2665:
2662:
2660:
2657:
2655:
2652:
2650:
2647:
2645:
2642:
2640:
2639:Cultured meat
2637:
2635:
2632:
2630:
2627:
2626:
2624:
2622:Biology field
2620:
2617:
2611:
2605:
2602:
2600:
2597:
2595:
2592:
2590:
2587:
2585:
2582:
2580:
2577:
2576:
2574:
2570:
2564:
2561:
2559:
2556:
2554:
2551:
2549:
2546:
2544:
2541:
2539:
2535:
2532:
2530:
2527:
2525:
2522:
2521:
2519:
2515:
2509:
2506:
2504:
2501:
2500:
2498:
2494:
2489:
2479:
2476:
2474:
2471:
2469:
2466:
2465:
2463:
2459:
2455:
2454:Biotechnology
2448:
2443:
2441:
2436:
2434:
2429:
2428:
2425:
2411:on 2006-01-01
2410:
2406:
2402:
2388:
2383:
2373:on 2007-09-27
2369:
2362:
2357:
2354:
2350:
2347:
2346:
2328:
2322:
2303:
2302:
2294:
2286:
2279:
2272:
2257:
2253:
2247:
2230:
2223:
2215:
2211:
2207:
2203:
2199:
2198:10.1038/80231
2195:
2191:
2187:
2180:
2172:
2168:
2164:
2160:
2156:
2152:
2148:
2144:
2137:
2123:
2119:
2113:
2099:
2098:
2093:
2086:
2070:
2066:
2060:
2046:on 2006-03-16
2045:
2041:
2034:
2026:
2019:
2013:
2010:
2004:
1990:on 2017-03-15
1986:
1979:
1972:
1958:
1954:
1950:
1946:
1942:
1938:
1934:
1927:
1925:
1916:
1912:
1907:
1902:
1898:
1894:
1890:
1883:
1875:
1871:
1866:
1861:
1857:
1853:
1849:
1842:
1834:
1830:
1825:
1820:
1815:
1810:
1806:
1802:
1798:
1791:
1789:
1774:on 2018-10-03
1773:
1769:
1762:
1754:
1750:
1746:
1739:
1731:
1727:
1723:
1719:
1712:
1705:
1697:
1693:
1689:
1685:
1681:
1674:
1672:
1656:
1649:
1635:
1634:
1629:
1623:
1609:
1608:
1603:
1597:
1579:
1572:
1556:
1552:
1545:
1537:
1533:
1528:
1523:
1519:
1515:
1511:
1507:
1503:
1496:
1488:
1482:
1478:
1471:
1455:
1451:
1445:
1437:
1433:
1428:
1423:
1420:(7): 743–51.
1419:
1415:
1411:
1404:
1396:
1392:
1388:
1384:
1380:
1376:
1372:
1365:
1357:
1353:
1349:
1345:
1340:
1335:
1331:
1327:
1323:
1316:
1308:
1304:
1300:
1294:
1290:
1280:
1277:
1275:
1272:
1270:
1267:
1265:
1262:
1260:
1257:
1255:
1252:
1251:
1244:
1242:
1241:Health Canada
1238:
1228:
1226:
1222:
1218:
1214:
1210:
1209:United States
1203:United States
1197:
1193:
1192:gene transfer
1189:
1186:
1182:
1181:proteinaceous
1178:
1174:
1171:
1167:
1166:
1165:
1163:
1148:
1146:
1142:
1138:
1133:
1128:
1125:
1121:
1115:
1105:
1103:
1099:
1095:
1091:
1087:
1083:
1079:
1075:
1071:
1067:
1066:
1056:
1047:
1045:
1041:
1036:
1032:
1031:United States
1028:
1024:
1014:
1011:
1007:
1003:
1000:In 2003, the
998:
994:
992:
988:
984:
980:
976:
972:
968:
962:
952:
949:
947:
943:
934:
930:
915:
912:
909:
907:
903:
899:
895:
892:
889:
887:
884:
883:
879:
868:
865:
863:
859:
856:
853:
851:
848:
847:
844:
841:
838:
836:
833:
831:
827:
823:
819:
816:
813:
811:
808:
807:
803:
802:Interleukin-2
800:
797:
794:
791:
789:
786:
785:
781:
777:
774:
771:
768:
766:
762:
758:
754:
751:
748:
746:
743:
742:
738:
735:
732:
729:
727:
726:breast cancer
724:
721:
719:
716:
715:
711:
708:
706:
702:
698:
695:
693:
690:
689:
685:
682:
679:
676:
674:
671:
670:
666:
664:
661:
658:
654:
650:
647:
644:
642:
639:
638:
634:
631:
629:
625:
622:
620:
617:
616:
613:
610:
607:
605:
602:
600:
596:
593:, psoriasis,
592:
588:
584:
581:
579:
576:
575:
572:deactivation
571:
568:
566:
563:
560:
557:
555:
552:
549:
547:
544:
543:
539:
536:
533:
530:
528:
524:
521:
520:
517:
515:
507:
503:
500:
497:
494:
490:
486:
483:
480:
477:
474:
471:
468:
464:
460:
457:
453:
450:
447:
443:
440:
436:
432:
431:
430:
427:
425:
421:
417:
414:
410:
406:
401:
399:
395:
391:
387:
382:
380:
376:
372:
368:
364:
360:
356:
348:
344:
340:
336:
332:
328:
325:
322:
318:
314:
313:erythropoetin
310:
309:
308:
306:
301:
296:
286:
284:
277:
274:
272:
268:
266:
263:
260:
256:
252:
249:
247:
244:
242:
238:
235:
232:
229:
228:
227:
216:
212:
206:Major classes
203:
201:
196:
192:
190:
186:
181:
179:
175:
171:
167:
163:
159:
155:
154:pharmaceutics
151:
147:
143:
139:
135:
131:
127:
122:
120:
116:
112:
111:nucleic acids
108:
104:
100:
96:
92:
88:
84:
80:
79:somatic cells
76:
72:
68:
64:
60:
56:
52:
48:
44:
40:
33:
19:
3002:
2990:
2927:Microbiology
2912:Biochemicals
2891:
2824:Gene therapy
2765:Biosynthesis
2743:Applications
2664:Spectroscopy
2634:Cell culture
2543:Fermentation
2413:. Retrieved
2409:the original
2394:. Retrieved
2375:. Retrieved
2368:the original
2330:. Retrieved
2321:
2309:. Retrieved
2300:
2293:
2284:
2271:
2260:. Retrieved
2258:. 2006-06-02
2255:
2246:
2235:. Retrieved
2222:
2189:
2185:
2179:
2146:
2142:
2136:
2125:. Retrieved
2121:
2112:
2101:. Retrieved
2095:
2085:
2073:. Retrieved
2068:
2059:
2048:. Retrieved
2044:the original
2033:
2024:
2003:
1992:. Retrieved
1985:the original
1971:
1960:. Retrieved
1940:
1936:
1896:
1892:
1882:
1858:(4): 310–2.
1855:
1851:
1841:
1804:
1800:
1776:. Retrieved
1772:the original
1761:
1752:
1748:
1738:
1721:
1717:
1704:
1679:
1659:. Retrieved
1648:
1637:, retrieved
1632:
1622:
1611:, retrieved
1606:
1596:
1586:24 September
1584:. Retrieved
1571:
1559:. Retrieved
1554:
1544:
1512:(7): 542–8.
1509:
1505:
1495:
1476:
1470:
1458:. Retrieved
1456:. 2 Feb 2012
1444:
1417:
1413:
1403:
1378:
1374:
1364:
1329:
1325:
1315:
1307:the original
1302:
1299:"Biological"
1293:
1279:Nanomedicine
1234:
1206:
1196:cell therapy
1159:
1129:
1117:
1070:Cell culture
1064:
1061:
1020:
1005:
999:
995:
987:immunoassays
964:
950:
940:
937:Gene therapy
932:
916:neutralizer
653:chemotherapy
559:immunoglobin
511:
428:
402:
383:
355:rheumatology
352:
347:pharmacology
299:
298:
280:
225:
215:Blood plasma
197:
193:
182:
177:
173:
162:pharmacology
157:
149:
142:nucleic acid
133:
129:
123:
99:cell therapy
46:
42:
38:
36:
2917:Biorobotics
2907:Biomimetics
2902:Biomedicine
1576:Murphy CO.
1108:Transgenics
1082:bioreactors
1040:spermatozoa
1027:patent laws
955:Biosimilars
850:vedolizumab
782:antagonist
745:ustekinumab
718:trastuzumab
537:Technology
534:Indication
531:Trade name
489:Hepatitis B
479:Interleukin
473:Interferons
435:Factor VIII
367:dermatology
361:, but also
271:breast milk
231:Whole blood
185:biomedicine
75:allergenics
71:whole blood
3020:Categories
2872:Bioeconomy
2844:Stem cells
2797:Embryology
2720:Filtration
2710:Extraction
2629:Bioreactor
2415:2007-12-17
2396:2007-12-17
2377:2007-12-17
2332:2019-01-20
2262:2006-10-25
2237:2006-06-23
2149:(1): 3–9.
2127:2016-09-29
2103:2016-09-29
2050:2006-06-23
1994:2014-10-11
1962:2012-06-13
1778:2009-03-11
1755:: 175–180.
1661:2014-02-09
1639:2017-05-15
1613:2017-05-15
1286:References
1198:materials.
1151:Regulation
1120:transgenic
1098:mycoplasma
1080:plants in
961:Biosimilar
886:ixekizumab
843:antagonist
722:Herceptin
692:infliximab
673:etanercept
612:antagonist
578:adalimumab
413:trade name
398:malignancy
363:cardiology
293:See also:
261:infection)
251:Antibodies
115:precursors
59:biological
2715:Fed Batch
2615:and tools
2069:phrma.org
1937:Pharm Med
1696:2731-6092
1561:5 October
1348:1087-0156
1225:cleanroom
1044:egg cells
810:golimumab
770:humanized
757:psoriasis
731:humanized
696:Remicade
628:psoriasis
619:alefacept
546:abatacept
501:(Various)
439:Factor IX
420:Genentech
407:made via
375:neurology
331:hybridoma
300:Biologics
49:, is any
3051:Pharmacy
2992:Category
2947:Virology
2849:Telomere
2496:Branches
2311:11 April
2256:BBC News
2214:10154550
2206:11017040
2163:17701058
2075:11 April
1957:14604362
1915:29285958
1874:21478841
1833:24281342
1730:18958946
1536:23964615
1527:10437312
1436:18612293
1395:22995556
1356:30520869
1247:See also
1090:bacteria
923:Vaccines
880:blocker
878:integrin
854:Entyvio
814:Simponi
749:Stelara
737:HER2/neu
623:Amevive
550:Orencia
491:surface
485:Vaccines
452:Hormones
359:oncology
107:proteins
97:used in
67:vaccines
47:biologic
3004:Commons
2887:Biology
2780:Cloning
2558:Protein
2553:Plasmid
2461:History
2171:4673669
2071:. PhRMA
1824:3816668
1460:8 April
1207:In the
1160:In the
1094:viruses
1065:E. coli
1029:in the
967:patents
929:Vaccine
677:Enbrel
659:, etc.
645:Epogen
582:Humira
493:antigen
456:insulin
416:Humulin
405:insulin
321:insulin
144:-based
87:tissues
2932:Mining
2865:fields
2524:Allele
2355:(MeSH)
2212:
2204:
2169:
2161:
2097:Forbes
1955:
1913:
1872:
1831:
1821:
1728:
1694:
1534:
1524:
1483:
1434:
1393:
1354:
1346:
1237:Canada
1231:Canada
1170:plasma
1076:) and
1035:Europe
1023:patent
914:IL-17A
890:Taltz
792:Ontak
649:anemia
570:T-cell
562:CTLA-4
334:below.
269:Human
119:living
103:sugars
93:, and
2956:Lists
2834:Omics
2390:(PDF)
2371:(PDF)
2364:(PDF)
2305:(PDF)
2281:(PDF)
2232:(PDF)
2210:S2CID
2167:S2CID
2021:(PDF)
2012:61497
1988:(PDF)
1981:(PDF)
1953:S2CID
1714:(PDF)
1581:(PDF)
1183:, or
1141:ATryn
946:virus
780:IL-23
776:IL-12
392:, or
259:virus
146:drugs
57:from
45:, or
2685:CSTR
2654:HPLC
2548:Gene
2529:Cell
2313:2018
2202:PMID
2159:PMID
2077:2018
1911:PMID
1870:PMID
1829:PMID
1726:PMID
1692:ISSN
1588:2015
1563:2015
1532:PMID
1481:ISBN
1462:2014
1432:PMID
1391:PMID
1352:PMID
1344:ISSN
1139:was
1137:goat
1078:moss
1042:and
1033:and
969:for
778:and
523:USAN
437:and
357:and
253:for
239:and
187:and
2725:PFR
2659:NMR
2538:RNA
2534:DNA
2194:doi
2151:doi
2007:75
1945:doi
1901:doi
1860:doi
1819:PMC
1809:doi
1684:doi
1522:PMC
1514:doi
1422:doi
1383:doi
1334:doi
1235:In
1104:).
840:TNF
609:TNF
527:INN
152:is
132:or
3022::
2283:.
2254:.
2208:.
2200:.
2190:18
2188:.
2165:.
2157:.
2147:31
2145:.
2120:.
2094:.
2067:.
2023:.
2014:;
2009:FR
1951:.
1941:26
1939:.
1935:.
1923:^
1909:.
1897:18
1895:.
1891:.
1868:.
1856:29
1854:.
1850:.
1827:.
1817:.
1803:.
1799:.
1787:^
1753:27
1751:.
1747:.
1722:73
1720:.
1716:.
1690:.
1682:.
1670:^
1630:,
1553:.
1530:.
1520:.
1510:19
1508:.
1504:.
1452:.
1430:.
1418:26
1416:.
1412:.
1389:.
1379:30
1377:.
1373:.
1350:.
1342:.
1330:36
1328:.
1324:.
1301:.
1243:.
1096:,
1092:,
989:,
985:,
904:,
900:,
896:,
860:,
828:,
824:,
820:,
763:,
759:,
755:,
703:,
655:,
597:,
589:,
465:,
400:.
388:,
373:,
369:,
365:,
285:.
202:.
109:,
105:,
89:,
85:,
81:,
77:,
69:,
37:A
2536:/
2446:e
2439:t
2432:v
2418:.
2399:.
2380:.
2335:.
2315:.
2265:.
2240:.
2216:.
2196::
2173:.
2153::
2130:.
2106:.
2079:.
2053:.
2027:.
1997:.
1965:.
1947::
1917:.
1903::
1876:.
1862::
1835:.
1811::
1805:5
1781:.
1732:.
1698:.
1686::
1664:.
1642:.
1616:.
1590:.
1565:.
1538:.
1516::
1489:.
1464:.
1438:.
1424::
1397:.
1385::
1358:.
1336::
875:7
873:β
871:4
869:α
525:/
495:)
487:(
469:)
454:(
448:)
441:)
34:.
20:)
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.