1027:
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
366:, 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
1044:
2477:
2976:
970:, 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.,
200:
1153:, 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:
2988:
370:, 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.
1001:
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.
1115:
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
1026:
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,
985:
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
1212:, 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
322:
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
165:(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
183:
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.
291:
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
1123:
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
2288:
113:
Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some
1119:
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
2315:
1014:, 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
2053:
334:
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
2267:"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"
2961:
1157:
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
1966:
501:
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
2080:
1566:
997:. This pathway is based on a thorough demonstration of comparability of the product to an existing approved product. Within the United States, the
318:. These are similar to the antibodies that the human immune system uses to fight off bacteria and viruses, but they are "custom-designed" (using
2393:
137:, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.
1216:
environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug.
1667:
Pasin, Fabio; Uranga, Mireia; Charudattan, Raghavan; Kwon, Choon-Tak (2024-05-15). "Engineering good viruses to improve crop performance".
1201:
215:
Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include:
1539:
1756:
2028:
998:
940:
Viral gene therapies using engineered plant viruses have been proposed to enhance crop performance and promote sustainable production.
2266:
1620:
1077:. Important issues of concern are cost of production (low-volume, high-purity products are desirable) and microbial contamination (by
2466:
894:
300:
Substances that are (nearly) identical to the body's key signaling proteins. Examples are the blood-production stimulating protein
2433:
2130:
Decker EL, Reski R (January 2008). "Current achievements in the production of complex biopharmaceuticals with moss bioreactors".
1205:
1594:
2642:
2349:
1473:
1287:
1973:
342:
Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily
1200:, biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's
1700:"Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule"
515:
1733:
962:
between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. Compared to
3034:
1257:
1228:, biologics (and radiopharmaceuticals) are reviewed through the Biologics and Genetic Therapies Directorate within
3029:
3019:
2951:
2673:
283:
2992:
2956:
270:
Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by
2800:
2567:
1442:
1262:
434:
187:
In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and
3014:
2790:
2426:
828:
597:
264:
1489:
Gleason PP, Alexander GC, Starner CI, Ritter ST, Van Houten HK, Gunderson BW, Shah ND (September 2013).
180:, and may be used to treat a variety of medical conditions for which no other treatments are available.
110:
sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
2647:
2006:
1090:
511:
2461:
2217:
1876:
Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M (April 2018).
1699:
1616:
1590:
1133:
990:
455:
158:
1120:
3044:
2817:
2496:
2456:
2397:
2341:
1180:
1015:
2713:
2491:
1643:
1438:
1359:
1242:
102:, or complex combinations of these substances, or may be living cells or tissues. They (or their
157:, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The
3024:
2980:
2885:
2870:
2698:
2592:
2572:
2419:
2337:
890:
814:
575:
494:
382:
169:
refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.
1136:
in
February 2006. This decision was reversed in June 2006 and approval was given August 2006.
1760:
971:
645:
412:
225:
103:
2032:
2910:
2773:
2637:
2587:
2375:
1062:
806:
542:
374:
79:
2290:
Key
Regulatory Guidelines for the Development of Biologics in the United States and Europe
8:
2795:
2778:
2758:
2738:
1247:
1112:
1102:
886:
831:
823:
810:
776:
741:
651:
600:
592:
579:
487:
385:
are at increased risk for life-threatening infection, adverse cardiovascular events, and
378:
315:
253:
177:
39:
20:
2240:
1515:
1490:
2805:
2551:
2198:
2155:
2000:
1967:"Questions and answers on biosimilar medicines (similar biological medicinal products)"
1941:
1812:
1785:
967:
930:
850:
846:
818:
758:
753:
749:
719:
693:
689:
587:
583:
3039:
2930:
2925:
2703:
2577:
2190:
2147:
1921:
1899:
1858:
1817:
1714:
1680:
1520:
1469:
1420:
1379:
1340:
1332:
1252:
1074:
979:
234:
229:
114:
2202:
1945:
1757:"Biopharmaceutical sector sees rising R&D despite credit crunch, finds analysis"
1089:). Alternative platforms of production which are being tested include whole plants (
2860:
2827:
2582:
2356:
2182:
2159:
2139:
1997:
1933:
1889:
1848:
1807:
1797:
1672:
1510:
1502:
1410:
1371:
1322:
1052:
959:
882:
367:
359:
243:
75:
1894:
1877:
1491:"Health plan utilization and costs of specialty drugs within 4 chronic conditions"
1375:
1295:
1010:
When a new biopharmaceutical is developed, the company will typically apply for a
2693:
2688:
2678:
963:
787:
Diphtheria toxin engineered protein combining
Interleukin-2 and Diphtheria toxin
502:
397:
293:
271:
154:
83:
51:
2376:"Report for USA Specialty Pharmaceuticals: Generic Biologics: The Next Frontier"
1506:
2865:
2842:
2748:
2743:
2683:
2668:
2632:
2517:
1878:"Maintaining consistent quality and clinical performance of biopharmaceuticals"
1676:
1209:
1173:
1150:
768:
764:
629:
553:
451:
392:
The first such substance approved for therapeutic use was biosynthetic "human"
331:
327:
305:
188:
2143:
688:
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis,
172:
Gene-based and cellular biologics, for example, often are at the forefront of
3008:
2763:
2718:
2627:
2442:
1837:"Acceptable changes in quality attributes of glycosylated biopharmaceuticals"
1835:
Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R (April 2011).
1684:
1336:
1229:
1197:
1169:
1165:
1019:
790:
714:
669:
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis
301:
142:
126:
43:
1786:"Biosimilars: company strategies to capture value from the biologics market"
1641:
1107:
A potentially controversial method of producing biopharmaceuticals involves
2915:
2900:
2812:
2753:
2652:
2622:
2531:
2194:
2151:
2106:
1903:
1862:
1821:
1718:
1524:
1424:
1383:
1344:
1267:
1184:
1158:
1058:
1051:
Biopharmaceuticals may be produced from microbial cells (e.g., recombinant
1028:
641:
547:
343:
335:
203:
150:
130:
99:
87:
71:
67:
2264:
2029:"Patenting in the Biopharmaceutical Industry—comparing the US with Europe"
2004:
1697:
2905:
2895:
2890:
2007:"Approval Pathway for Biosimilar and Interchangeable Biological Products"
975:
838:
733:
706:
477:
467:
423:
355:
259:
219:
173:
59:
2476:
1415:
1398:
1176:
components originating from a microbial, animal, human, or plant source.
1043:
2832:
2785:
2708:
2617:
1937:
1108:
1086:
1070:
949:
874:
680:
661:
566:
461:
401:
386:
351:
63:
1802:
206:
is a type of biopharmaceutical directly extracted from living systems.
1853:
1836:
1327:
1310:
1213:
798:
745:
616:
607:
534:
427:
408:
363:
319:
199:
2935:
2837:
2218:"European Regulators Curdle Plans for Goat Milk Human Antithrombin"
1179:
Mode of action – therapeutic and immunological medicinal products,
1078:
1032:
866:
725:
347:
239:
2186:
1466:
Biopharmaceuticals: Biochemistry and
Biotechnology, Second Edition
2875:
2768:
2546:
2541:
955:
917:
481:
473:
444:
440:
404:
393:
373:
Older patients who receive biologic therapy for diseases such as
330:), usually based on a naturally occurring receptor linked to the
309:
95:
55:
47:
2411:
1834:
2920:
2512:
2085:
1922:"The US Biosimilars Act: Challenges Facing Regulatory Approval"
1593:, "tooltip definition of advanced therapy medicinal products",
1225:
1023:
1011:
637:
558:
550:
1783:
982:, etc.) and describe a unique design space for each biologic.
296:
technology. These medications are usually one of three types:
2962:
List of largest biomedical companies by market capitalization
2822:
1488:
1129:
1082:
934:
902:
247:
91:
2536:
2396:. National Psoriasis Foundation. 2006-11-01. Archived from
2355:. Biotechnology Industry Organization (BIO). Archived from
1642:
Center for
Biologics Evaluation and Research (2010-04-01).
1537:
1125:
1066:
134:
107:
1698:
1666:
1111:
organisms, particularly plants and animals that have been
2526:
2522:
2265:
The
Commission of the European Communities (2003-06-25).
2054:"Growth and Policies Behind Biopharmaceutical Innovation"
2005:
2373:
2173:
Dove A (October 2000). "Milking the genome for profit".
1734:"The use of biologic agents in the geriatric population"
1540:"Specialty Pharmacies Proliferate, Along With Questions"
2020:
1875:
1784:
Calo-Fernández B, MartĂnez-Hurtado JL (December 2012).
993:
introduced an adapted pathway for biosimilars, termed
1615:
1589:
1531:
415:, who manufactured and marketed it starting in 1982.
2286:
1915:
1913:
986:than for registering completely new therapeutics.
937:to include a desirable piece of genetic material.
2347:
19:"Biologics" redirects here. For the journal, see
3006:
1047:Stainless steel bioreactor for production plants
210:
2258:
2215:
1910:
1990:
1779:
1777:
1754:
1538:Thomas, Kate; Pollack, Andrew (15 July 2015).
1132:, but marketing permission was blocked by the
1057:or yeast cultures), mammalian cell lines (see
672:recombinant human TNF-receptor fusion protein
338:. Some examples are listed in the table below.
277:
2427:
2316:"Biologics and Genetic Therapies Directorate"
1622:Advanced therapy medicinal products: Overview
2296:. John Wiley & Sons, Inc. pp. 75–88
2166:
2123:
1828:
1691:
1567:"Specialty Pharmacy Managed Care Strategies"
1202:Center for Biologics Evaluation and Research
922:Many vaccines are grown in tissue cultures.
42:product manufactured in, extracted from, or
2129:
1972:. European Medicines Agency. Archived from
1774:
1390:
1161:-derived products and a number of vaccines.
447:, glucagon, growth hormone, gonadotrophins)
418:Major kinds of biopharmaceuticals include:
304:, or the growth-stimulating hormone named "
2434:
2420:
2081:"The Guys Who Trade Your Blood For Profit"
1204:(CBER) whereas drugs are regulated by the
999:Patient Protection and Affordable Care Act
400:. Sometimes referred to as rHI, under the
2374:Timothy B. Coan; Ron Ellis (2001-06-01).
2340:at the U.S. National Library of Medicine
1893:
1852:
1811:
1801:
1609:
1514:
1414:
1357:
1326:
1038:
656:stimulation of red blood cell production
2467:Competitions and prizes in biotechnology
1482:
1208:. Approval may require several years of
1164:Active substance – consisting of entire
1042:
895:non-radiographic axial spondyloarthritis
198:
2107:"Sperm Donors Australia | Donate Sperm"
1635:
1583:
1206:Center for Drug Evaluation and Research
3007:
2274:Official Journal of the European Union
1596:Committee for Advanced Therapies (CAT)
1358:Ryan, Michael P.; Walsh, Gary (2012).
2415:
2287:Kingham R, Klasa G, Carver K (2014).
2132:Bioprocess and Biosystems Engineering
1662:
1660:
1463:
1396:
1360:"Veterinary-based biopharmaceuticals"
1308:
1073:of various configurations, including
1035:can be used for fertility treatment.
995:similar biological medicinal products
966:that consist of chemically identical
933:involves artificially manipulating a
2987:
2172:
2014:Public Hearing; Request for Comments
1958:
1919:
1882:Expert Opinion on Biological Therapy
1731:
1005:
145:that works with biopharmaceuticals.
125:to refer specifically to engineered
2078:
1964:
1646:. U.S. Food and Drug Administration
1558:
1311:"Biopharmaceutical benchmarks 2018"
163:advanced therapy medicinal products
13:
2241:"Go-ahead for 'pharmed' goat drug"
2026:
1657:
1564:
1168:, mammalian cells, nucleic acids,
14:
3056:
2441:
2331:
1144:
784:cutaneous T-cell lymphoma (CTCL)
153:that studies biopharmaceuticals.
106:or components) are isolated from
2986:
2975:
2974:
2475:
2381:. Consumer Project on Technology
1495:Journal of Managed Care Pharmacy
1399:"(Re)defining biopharmaceutical"
1258:List of pharmaceutical companies
1191:
194:
16:Drug made from biological source
2952:Index of biotechnology articles
2308:
2280:
2233:
2209:
2099:
2072:
2046:
1869:
1748:
1725:
1644:"What is a biological product?"
1061:) and plant cell cultures (see
925:
621:immunoglobin G1 fusion protein
470:-based products (Interleukin-2)
450:Haematopoietic growth factors (
284:Biologics for immunosuppression
90:. Biologics can be composed of
80:recombinant therapeutic protein
2957:List of biotechnology articles
1457:
1431:
1351:
1302:
1280:
1096:
943:
899:humanized monoclonal antibody
123:therapeutic biological product
54:pharmaceuticals, they include
1:
2801:Genetically modified organism
2568:Biotechnology industrial park
1895:10.1080/14712598.2018.1421169
1669:Nature Reviews Bioengineering
1468:. John Wiley & Sons Ltd.
1439:"Drugs@FDA Glossary of Terms"
1376:10.1016/j.tibtech.2012.08.005
1274:
1139:
211:Extracted from living systems
119:biological medicinal products
1443:Food and Drug Administration
1263:List of recombinant proteins
954:With the expiration of many
435:tissue plasminogen activator
7:
2791:Environmental biotechnology
2111:spermdonorsaustralia.com.au
1507:10.18553/jmcp.2013.19.7.542
1235:
911:
624:incompletely characterized
278:Produced by recombinant DNA
129:products like protein- and
10:
3061:
2348:Debbie Strickland (2007).
1677:10.1038/s44222-024-00197-y
1100:
1091:plant-made pharmaceuticals
947:
915:
456:colony-stimulating factors
281:
222:and other blood components
32:biological medical product
18:
2970:
2944:
2851:
2731:
2661:
2610:
2601:
2560:
2505:
2484:
2473:
2462:Timeline of biotechnology
2449:
2144:10.1007/s00449-007-0151-y
1617:European Medicines Agency
1591:European Medicines Agency
1219:
1134:European Medicines Agency
1121:pronuclear microinjection
991:European Medicines Agency
159:European Medicines Agency
2818:Microbial biodegradation
2497:Industrial biotechnology
2457:History of biotechnology
2350:"Guide to Biotechnology"
2342:Medical Subject Headings
308:" or biosynthetic human
254:Human reproductive cells
50:sources. Different from
3035:Pharmaceutical industry
2492:Colors of biotechnology
1364:Trends in Biotechnology
1243:Antibody-drug conjugate
464:(Interferons-α, -β, -γ)
3030:Life sciences industry
3020:Biotechnology products
2886:Biomedical engineering
2593:Pharmaceutical company
2573:Biotechnology products
1397:Rader RA (July 2008).
1116:non-medical purposes.
1048:
1039:Large-scale production
891:ankylosing spondylitis
815:ankylosing spondylitis
576:ankylosing spondylitis
574:rheumatoid arthritis,
497:, therapeutic enzymes)
495:tumour necrosis factor
383:ankylosing spondylitis
207:
2216:Phillip B. C. Jones.
1046:
972:liquid chromatography
960:blockbuster biologics
646:chronic renal failure
493:Additional products (
488:Monoclonal antibodies
433:Thrombolytic agents (
413:Eli Lilly and Company
326:Receptor constructs (
316:Monoclonal antibodies
226:Organ transplantation
202:
2911:Chemical engineering
2774:Reproductive cloning
2638:Hybridoma technology
2588:Human Genome Project
2175:Nature Biotechnology
1841:Nature Biotechnology
1755:BriskFox Financial.
1546:. Sinking Spring, Pa
1403:Nature Biotechnology
1315:Nature Biotechnology
1309:Walsh, Gary (2018).
1298:on October 19, 2019.
1113:genetically modified
1063:Plant tissue culture
855:monoclonal antibody
807:rheumatoid arthritis
761:monoclonal antibody
722:monoclonal antibody
698:monoclonal antibody
640:arising from cancer
543:rheumatoid arthritis
529:Mechanism of action
505:technology include:
375:rheumatoid arthritis
62:, blood components,
2796:Genetic engineering
2779:Therapeutic cloning
2759:Bionic architecture
2739:Animal cell culture
2506:Biological concepts
2338:Biological Products
2276:. p. L 159/62.
1416:10.1038/nbt0708-743
1292:Oxford Dictionaries
1248:Genetic engineering
1103:Pharming (genetics)
887:psoriatic arthritis
824:monoclonal antibody
811:psoriatic arthritis
777:denileukin diftitox
742:psoriatic arthritis
728:(erbB2) antagonist
652:recombinant protein
593:monoclonal antibody
580:psoriatic arthritis
407:, was developed by
379:psoriatic arthritis
178:biomedical research
115:regulatory agencies
52:totally synthesized
40:pharmaceutical drug
21:Biologics (journal)
3015:Biopharmaceuticals
2852:Interdisciplinary
2806:Molecular genetics
2552:Selective breeding
1965:EMA (2008-10-30).
1938:10.1007/bf03262388
1049:
968:active ingredients
931:Viral gene therapy
847:ulcerative colitis
819:ulcerative colitis
750:ulcerative colitis
690:ulcerative colitis
584:ulcerative colitis
411:, but licensed to
312:and its analogues.
246:(e.g., to treat a
230:tissue transplants
208:
167:advanced therapies
30:, also known as a
3002:
3001:
2931:Nanobiotechnology
2926:Molecular biology
2727:
2726:
2578:Biotechnology law
2394:"About biologics"
1803:10.3390/ph5121393
1738:J Musculoskel Med
1713:(164): 49603–10.
1475:978-0-470-84326-0
1321:(12): 1136–1145.
1253:Host cell protein
1075:photo-bioreactors
1006:Commercialization
980:mass spectrometry
909:
908:
235:Stem-cell therapy
149:is the branch of
28:biopharmaceutical
3052:
2990:
2989:
2978:
2977:
2828:Pharmacogenomics
2608:
2607:
2602:Basic techniques
2583:Green Revolution
2561:General concepts
2479:
2436:
2429:
2422:
2413:
2412:
2408:
2406:
2405:
2389:
2387:
2386:
2380:
2370:
2368:
2367:
2361:
2354:
2326:
2325:
2323:
2322:
2312:
2306:
2305:
2303:
2301:
2295:
2284:
2278:
2277:
2271:
2262:
2256:
2255:
2253:
2252:
2237:
2231:
2230:
2228:
2227:
2222:
2213:
2207:
2206:
2170:
2164:
2163:
2127:
2121:
2120:
2118:
2117:
2103:
2097:
2096:
2094:
2093:
2076:
2070:
2069:
2067:
2065:
2050:
2044:
2043:
2041:
2040:
2031:. Archived from
2024:
2018:
2017:
2011:
1994:
1988:
1987:
1985:
1984:
1978:
1971:
1962:
1956:
1955:
1953:
1952:
1917:
1908:
1907:
1897:
1873:
1867:
1866:
1856:
1854:10.1038/nbt.1839
1832:
1826:
1825:
1815:
1805:
1796:(12): 1393–408.
1781:
1772:
1771:
1769:
1768:
1759:. Archived from
1752:
1746:
1745:
1732:Kerr LD (2010).
1729:
1723:
1722:
1707:Federal Register
1704:
1695:
1689:
1688:
1664:
1655:
1654:
1652:
1651:
1639:
1633:
1632:
1630:
1629:
1613:
1607:
1606:
1604:
1603:
1587:
1581:
1580:
1578:
1576:
1571:
1562:
1556:
1555:
1553:
1551:
1535:
1529:
1528:
1518:
1486:
1480:
1479:
1464:Walsh G (2003).
1461:
1455:
1454:
1452:
1450:
1435:
1429:
1428:
1418:
1394:
1388:
1387:
1355:
1349:
1348:
1330:
1328:10.1038/nbt.4305
1306:
1300:
1299:
1294:. Archived from
1284:
883:plaque psoriasis
793:receptor binder
508:
507:
368:chronic diseases
360:gastroenterology
265:Fecal microbiota
244:passive immunity
139:Biopharmaceutics
84:living medicines
3060:
3059:
3055:
3054:
3053:
3051:
3050:
3049:
3045:Specialty drugs
3005:
3004:
3003:
2998:
2966:
2940:
2881:Biopharmacology
2853:
2847:
2723:
2694:Electrophoresis
2689:Kidney dialysis
2679:Crystallization
2657:
2603:
2597:
2556:
2501:
2480:
2471:
2445:
2440:
2403:
2401:
2392:
2384:
2382:
2378:
2365:
2363:
2359:
2352:
2334:
2329:
2320:
2318:
2314:
2313:
2309:
2299:
2297:
2293:
2285:
2281:
2269:
2263:
2259:
2250:
2248:
2239:
2238:
2234:
2225:
2223:
2220:
2214:
2210:
2171:
2167:
2128:
2124:
2115:
2113:
2105:
2104:
2100:
2091:
2089:
2079:Carlyle, Erin.
2077:
2073:
2063:
2061:
2052:
2051:
2047:
2038:
2036:
2025:
2021:
2009:
1995:
1991:
1982:
1980:
1976:
1969:
1963:
1959:
1950:
1948:
1920:Nick C (2012).
1918:
1911:
1874:
1870:
1833:
1829:
1790:Pharmaceuticals
1782:
1775:
1766:
1764:
1753:
1749:
1730:
1726:
1702:
1696:
1692:
1665:
1658:
1649:
1647:
1640:
1636:
1627:
1625:
1614:
1610:
1601:
1599:
1588:
1584:
1574:
1572:
1569:
1563:
1559:
1549:
1547:
1536:
1532:
1487:
1483:
1476:
1462:
1458:
1448:
1446:
1437:
1436:
1432:
1395:
1391:
1370:(12): 615–620.
1356:
1352:
1307:
1303:
1286:
1285:
1281:
1277:
1272:
1238:
1222:
1210:clinical trials
1194:
1147:
1142:
1105:
1099:
1041:
1008:
964:small molecules
952:
946:
928:
920:
914:
865:
861:
851:Crohn's disease
754:Crohn's disease
701:TNF antagonist
694:Crohn's disease
675:TNF antagonist
615:chronic plaque
588:Crohn's disease
503:recombinant DNA
422:Blood factors (
398:recombinant DNA
328:fusion proteins
294:recombinant DNA
286:
280:
272:recombinant DNA
213:
197:
189:medical devices
155:Specialty drugs
147:Biopharmacology
44:semisynthesized
24:
17:
12:
11:
5:
3058:
3048:
3047:
3042:
3037:
3032:
3027:
3022:
3017:
3000:
2999:
2997:
2996:
2984:
2971:
2968:
2967:
2965:
2964:
2959:
2954:
2948:
2946:
2942:
2941:
2939:
2938:
2933:
2928:
2923:
2918:
2913:
2908:
2903:
2898:
2893:
2888:
2883:
2878:
2873:
2871:Bioengineering
2868:
2866:Bioelectronics
2863:
2857:
2855:
2849:
2848:
2846:
2845:
2843:Tissue culture
2840:
2835:
2830:
2825:
2820:
2815:
2810:
2809:
2808:
2803:
2793:
2788:
2783:
2782:
2781:
2776:
2766:
2761:
2756:
2751:
2749:Bioinformatics
2746:
2744:Biofabrication
2741:
2735:
2733:
2729:
2728:
2725:
2724:
2722:
2721:
2716:
2711:
2706:
2701:
2696:
2691:
2686:
2684:Chromatography
2681:
2676:
2671:
2669:Centrifugation
2665:
2663:
2662:Chemical field
2659:
2658:
2656:
2655:
2650:
2645:
2640:
2635:
2633:Flow cytometry
2630:
2625:
2620:
2614:
2612:
2605:
2599:
2598:
2596:
2595:
2590:
2585:
2580:
2575:
2570:
2564:
2562:
2558:
2557:
2555:
2554:
2549:
2544:
2539:
2534:
2529:
2520:
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2509:
2507:
2503:
2502:
2500:
2499:
2494:
2488:
2486:
2482:
2481:
2474:
2472:
2470:
2469:
2464:
2459:
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2451:
2447:
2446:
2439:
2438:
2431:
2424:
2416:
2410:
2409:
2390:
2371:
2345:
2333:
2332:External links
2330:
2328:
2327:
2307:
2279:
2257:
2232:
2208:
2181:(10): 1045–8.
2165:
2122:
2098:
2071:
2045:
2027:Foster, Luke.
2019:
1989:
1957:
1932:(3): 145–152.
1909:
1888:(4): 369–379.
1868:
1827:
1773:
1747:
1724:
1690:
1656:
1634:
1608:
1582:
1557:
1544:New York Times
1530:
1481:
1474:
1456:
1430:
1389:
1350:
1301:
1278:
1276:
1273:
1271:
1270:
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1255:
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1245:
1239:
1237:
1234:
1221:
1218:
1193:
1190:
1189:
1188:
1183:materials, or
1177:
1174:polysaccharide
1166:microorganisms
1162:
1151:European Union
1146:
1145:European Union
1143:
1141:
1138:
1101:Main article:
1098:
1095:
1040:
1037:
1007:
1004:
948:Main article:
945:
942:
927:
924:
916:Main article:
913:
910:
907:
906:
900:
897:
880:
877:
871:
870:
863:
859:
856:
853:
844:
841:
835:
834:
826:
821:
804:
801:
795:
794:
788:
785:
782:
779:
773:
772:
762:
756:
739:
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730:
729:
723:
717:
712:
709:
703:
702:
699:
696:
686:
683:
677:
676:
673:
670:
667:
664:
658:
657:
654:
649:
635:
632:
630:erythropoietin
626:
625:
622:
619:
613:
610:
604:
603:
595:
590:
572:
569:
563:
562:
556:
554:fusion protein
545:
540:
537:
531:
530:
527:
524:
521:
518:
499:
498:
491:
485:
471:
465:
459:
452:Erythropoietin
448:
438:
431:
340:
339:
332:immunoglobulin
324:
313:
306:growth hormone
279:
276:
268:
267:
262:
256:
251:
237:
232:
223:
212:
209:
196:
193:
161:uses the term
127:macromolecular
117:use the terms
72:gene therapies
15:
9:
6:
4:
3:
2:
3057:
3046:
3043:
3041:
3038:
3036:
3033:
3031:
3028:
3026:
3025:Biotechnology
3023:
3021:
3018:
3016:
3013:
3012:
3010:
2995:
2994:
2985:
2983:
2982:
2973:
2972:
2969:
2963:
2960:
2958:
2955:
2953:
2950:
2949:
2947:
2943:
2937:
2934:
2932:
2929:
2927:
2924:
2922:
2919:
2917:
2914:
2912:
2909:
2907:
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2902:
2899:
2897:
2894:
2892:
2889:
2887:
2884:
2882:
2879:
2877:
2874:
2872:
2869:
2867:
2864:
2862:
2859:
2858:
2856:
2850:
2844:
2841:
2839:
2836:
2834:
2831:
2829:
2826:
2824:
2821:
2819:
2816:
2814:
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2807:
2804:
2802:
2799:
2798:
2797:
2794:
2792:
2789:
2787:
2784:
2780:
2777:
2775:
2772:
2771:
2770:
2767:
2765:
2764:Cell immunity
2762:
2760:
2757:
2755:
2752:
2750:
2747:
2745:
2742:
2740:
2737:
2736:
2734:
2730:
2720:
2719:Sedimentation
2717:
2715:
2712:
2710:
2707:
2705:
2702:
2700:
2697:
2695:
2692:
2690:
2687:
2685:
2682:
2680:
2677:
2675:
2672:
2670:
2667:
2666:
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2660:
2654:
2651:
2649:
2646:
2644:
2641:
2639:
2636:
2634:
2631:
2629:
2628:Cultured meat
2626:
2624:
2621:
2619:
2616:
2615:
2613:
2611:Biology field
2609:
2606:
2600:
2594:
2591:
2589:
2586:
2584:
2581:
2579:
2576:
2574:
2571:
2569:
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2563:
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2553:
2550:
2548:
2545:
2543:
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2538:
2535:
2533:
2530:
2528:
2524:
2521:
2519:
2516:
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2511:
2510:
2508:
2504:
2498:
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2493:
2490:
2489:
2487:
2483:
2478:
2468:
2465:
2463:
2460:
2458:
2455:
2454:
2452:
2448:
2444:
2443:Biotechnology
2437:
2432:
2430:
2425:
2423:
2418:
2417:
2414:
2400:on 2006-01-01
2399:
2395:
2391:
2377:
2372:
2362:on 2007-09-27
2358:
2351:
2346:
2343:
2339:
2336:
2335:
2317:
2311:
2292:
2291:
2283:
2275:
2268:
2261:
2246:
2242:
2236:
2219:
2212:
2204:
2200:
2196:
2192:
2188:
2187:10.1038/80231
2184:
2180:
2176:
2169:
2161:
2157:
2153:
2149:
2145:
2141:
2137:
2133:
2126:
2112:
2108:
2102:
2088:
2087:
2082:
2075:
2059:
2055:
2049:
2035:on 2006-03-16
2034:
2030:
2023:
2015:
2008:
2002:
1999:
1993:
1979:on 2017-03-15
1975:
1968:
1961:
1947:
1943:
1939:
1935:
1931:
1927:
1923:
1916:
1914:
1905:
1901:
1896:
1891:
1887:
1883:
1879:
1872:
1864:
1860:
1855:
1850:
1846:
1842:
1838:
1831:
1823:
1819:
1814:
1809:
1804:
1799:
1795:
1791:
1787:
1780:
1778:
1763:on 2018-10-03
1762:
1758:
1751:
1743:
1739:
1735:
1728:
1720:
1716:
1712:
1708:
1701:
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1661:
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1638:
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1623:
1618:
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1534:
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1517:
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1508:
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1500:
1496:
1492:
1485:
1477:
1471:
1467:
1460:
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1422:
1417:
1412:
1409:(7): 743–51.
1408:
1404:
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1230:Health Canada
1227:
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1215:
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1198:United States
1192:United States
1186:
1182:
1181:gene transfer
1178:
1175:
1171:
1170:proteinaceous
1167:
1163:
1160:
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1152:
1137:
1135:
1131:
1127:
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1076:
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1020:United States
1017:
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989:In 2003, the
987:
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561:deactivation
560:
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317:
314:
311:
307:
303:
302:erythropoetin
299:
298:
297:
295:
290:
285:
275:
273:
266:
263:
261:
257:
255:
252:
249:
245:
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236:
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231:
227:
224:
221:
218:
217:
216:
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201:
195:Major classes
192:
190:
185:
181:
179:
175:
170:
168:
164:
160:
156:
152:
148:
144:
143:pharmaceutics
140:
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128:
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120:
116:
111:
109:
105:
101:
100:nucleic acids
97:
93:
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68:somatic cells
65:
61:
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53:
49:
45:
41:
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33:
29:
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2991:
2979:
2916:Microbiology
2901:Biochemicals
2880:
2813:Gene therapy
2754:Biosynthesis
2732:Applications
2653:Spectroscopy
2623:Cell culture
2532:Fermentation
2402:. Retrieved
2398:the original
2383:. Retrieved
2364:. Retrieved
2357:the original
2319:. Retrieved
2310:
2298:. Retrieved
2289:
2282:
2273:
2260:
2249:. Retrieved
2247:. 2006-06-02
2244:
2235:
2224:. Retrieved
2211:
2178:
2174:
2168:
2135:
2131:
2125:
2114:. Retrieved
2110:
2101:
2090:. Retrieved
2084:
2074:
2062:. Retrieved
2057:
2048:
2037:. Retrieved
2033:the original
2022:
2013:
1992:
1981:. Retrieved
1974:the original
1960:
1949:. Retrieved
1929:
1925:
1885:
1881:
1871:
1847:(4): 310–2.
1844:
1840:
1830:
1793:
1789:
1765:. Retrieved
1761:the original
1750:
1741:
1737:
1727:
1710:
1706:
1693:
1668:
1648:. Retrieved
1637:
1626:, retrieved
1621:
1611:
1600:, retrieved
1595:
1585:
1575:24 September
1573:. Retrieved
1560:
1548:. Retrieved
1543:
1533:
1501:(7): 542–8.
1498:
1494:
1484:
1465:
1459:
1447:. Retrieved
1445:. 2 Feb 2012
1433:
1406:
1402:
1392:
1367:
1363:
1353:
1318:
1314:
1304:
1296:the original
1291:
1288:"Biological"
1282:
1268:Nanomedicine
1223:
1195:
1185:cell therapy
1148:
1118:
1106:
1059:Cell culture
1053:
1050:
1009:
994:
988:
984:
976:immunoassays
953:
939:
929:
926:Gene therapy
921:
905:neutralizer
642:chemotherapy
548:immunoglobin
500:
417:
391:
372:
344:rheumatology
341:
336:pharmacology
288:
287:
269:
214:
204:Blood plasma
186:
182:
171:
166:
162:
151:pharmacology
146:
138:
131:nucleic acid
122:
118:
112:
88:cell therapy
35:
31:
27:
25:
2906:Biorobotics
2896:Biomimetics
2891:Biomedicine
1565:Murphy CO.
1097:Transgenics
1071:bioreactors
1029:spermatozoa
1016:patent laws
944:Biosimilars
839:vedolizumab
771:antagonist
734:ustekinumab
707:trastuzumab
526:Technology
523:Indication
520:Trade name
478:Hepatitis B
468:Interleukin
462:Interferons
424:Factor VIII
356:dermatology
350:, but also
260:breast milk
220:Whole blood
174:biomedicine
64:allergenics
60:whole blood
3009:Categories
2861:Bioeconomy
2833:Stem cells
2786:Embryology
2709:Filtration
2699:Extraction
2618:Bioreactor
2404:2007-12-17
2385:2007-12-17
2366:2007-12-17
2321:2019-01-20
2251:2006-10-25
2226:2006-06-23
2138:(1): 3–9.
2116:2016-09-29
2092:2016-09-29
2039:2006-06-23
1983:2014-10-11
1951:2012-06-13
1767:2009-03-11
1744:: 175–180.
1650:2014-02-09
1628:2017-05-15
1602:2017-05-15
1275:References
1187:materials.
1140:Regulation
1109:transgenic
1087:mycoplasma
1069:plants in
950:Biosimilar
875:ixekizumab
832:antagonist
711:Herceptin
681:infliximab
662:etanercept
601:antagonist
567:adalimumab
402:trade name
387:malignancy
352:cardiology
282:See also:
250:infection)
240:Antibodies
104:precursors
48:biological
2704:Fed Batch
2604:and tools
2058:phrma.org
1926:Pharm Med
1685:2731-6092
1550:5 October
1337:1087-0156
1214:cleanroom
1033:egg cells
799:golimumab
759:humanized
746:psoriasis
720:humanized
685:Remicade
617:psoriasis
608:alefacept
535:abatacept
490:(Various)
428:Factor IX
409:Genentech
396:made via
364:neurology
320:hybridoma
289:Biologics
38:, is any
3040:Pharmacy
2981:Category
2936:Virology
2838:Telomere
2485:Branches
2300:11 April
2245:BBC News
2203:10154550
2195:11017040
2152:17701058
2064:11 April
1946:14604362
1904:29285958
1863:21478841
1822:24281342
1719:18958946
1525:23964615
1516:10437312
1425:18612293
1384:22995556
1345:30520869
1236:See also
1079:bacteria
912:Vaccines
869:blocker
867:integrin
843:Entyvio
803:Simponi
738:Stelara
726:HER2/neu
612:Amevive
539:Orencia
480:surface
474:Vaccines
441:Hormones
348:oncology
96:proteins
86:used in
56:vaccines
36:biologic
2993:Commons
2876:Biology
2769:Cloning
2547:Protein
2542:Plasmid
2450:History
2160:4673669
2060:. PhRMA
1813:3816668
1449:8 April
1196:In the
1149:In the
1083:viruses
1054:E. coli
1018:in the
956:patents
918:Vaccine
666:Enbrel
648:, etc.
634:Epogen
571:Humira
482:antigen
445:insulin
405:Humulin
394:insulin
310:insulin
133:-based
76:tissues
2921:Mining
2854:fields
2513:Allele
2344:(MeSH)
2201:
2193:
2158:
2150:
2086:Forbes
1944:
1902:
1861:
1820:
1810:
1717:
1683:
1523:
1513:
1472:
1423:
1382:
1343:
1335:
1226:Canada
1220:Canada
1159:plasma
1065:) and
1024:Europe
1012:patent
903:IL-17A
879:Taltz
781:Ontak
638:anemia
559:T-cell
551:CTLA-4
323:below.
258:Human
108:living
92:sugars
82:, and
2945:Lists
2823:Omics
2379:(PDF)
2360:(PDF)
2353:(PDF)
2294:(PDF)
2270:(PDF)
2221:(PDF)
2199:S2CID
2156:S2CID
2010:(PDF)
2001:61497
1977:(PDF)
1970:(PDF)
1942:S2CID
1703:(PDF)
1570:(PDF)
1172:, or
1130:ATryn
935:virus
769:IL-23
765:IL-12
381:, or
248:virus
135:drugs
46:from
34:, or
2674:CSTR
2643:HPLC
2537:Gene
2518:Cell
2302:2018
2191:PMID
2148:PMID
2066:2018
1900:PMID
1859:PMID
1818:PMID
1715:PMID
1681:ISSN
1577:2015
1552:2015
1521:PMID
1470:ISBN
1451:2014
1421:PMID
1380:PMID
1341:PMID
1333:ISSN
1128:was
1126:goat
1067:moss
1031:and
1022:and
958:for
767:and
512:USAN
426:and
346:and
242:for
228:and
176:and
2714:PFR
2648:NMR
2527:RNA
2523:DNA
2183:doi
2140:doi
1996:75
1934:doi
1890:doi
1849:doi
1808:PMC
1798:doi
1673:doi
1511:PMC
1503:doi
1411:doi
1372:doi
1323:doi
1224:In
1093:).
829:TNF
598:TNF
516:INN
141:is
121:or
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