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1

Feng, Xiaodong, Hong-Guang Xie, Ashim Malhotra, and Catherine F. Yang. Biologics and Biosimilars. CRC Press, 2022. http://dx.doi.org/10.1201/9780429485626.

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2

Boehncke, Wolf-Henning, and Heinfried H. Radeke, eds. Biologics in General Medicine. Springer Berlin Heidelberg, 2007. http://dx.doi.org/10.1007/978-3-540-29018-6.

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3

Varshney, Dushyant, and Manmohan Singh, eds. Lyophilized Biologics and Vaccines. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2383-0.

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4

Baldo, Brian A. Safety of Biologics Therapy. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-30472-4.

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5

Directorate, Canada Drugs. Inspection of biologics manufacturers. Health and Welfare Canada = Santé et bien-être social Canada, 1992.

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6

AGRICULTURE, US DEPARTMENT OF. Veterinary biologics: use and regulation. U.S. Dept. of Agriculture, 1989.

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7

P, Mathieu Mark, ed. Biologics development: A regulatory overview. PAREXEL International Corp., 1993.

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8

Crandall, Mary Anne. The market for generic biologics. Edited by Heffner Steven and Kalorama Information LLC. Kalorama Information, 2004.

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9

United States. Animal and Plant Health Inspection Service. Veterinary biologics: Use and regulation. 2nd ed. U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, 2013.

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10

United States. Animal and Plant Health Inspection Service, ed. Veterinary biologics: Use and regulation. U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, 2002.

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11

Gay, Cyril G. Risk analysis for veterinary biologics. Animal and Plant Health Inspection Service, U.S. Dept. of Agriculture, 1994.

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12

P, Mathieu Mark, ed. Biologics development: A regulatory overview. 2nd ed. PAREXEL International Corp., 1997.

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13

Jain, Neeraj, and Lalit Duggal, eds. Handbook of Biologics for Rheumatological Disorders. Springer Singapore, 2022. http://dx.doi.org/10.1007/978-981-16-7200-2.

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14

Zhou, Weichang, and Anne Kantardjieff, eds. Mammalian Cell Cultures for Biologics Manufacturing. Springer Berlin Heidelberg, 2014. http://dx.doi.org/10.1007/978-3-642-54050-9.

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15

Montoya, Ivan D., ed. Biologics to Treat Substance Use Disorders. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-23150-1.

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16

Ekins, Sean, and Jinghai J. Xu, eds. Drug Efficacy, Safety, and Biologics Discovery. John Wiley & Sons, Inc., 2008. http://dx.doi.org/10.1002/9780470431818.

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17

Gutiérrez, Daniel J. Follow-on biologics: Background and issues. Nova Science, 2011.

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18

Randolph, Thomas C. Use of biologics, chemicals, and drugs. United StatesDepartment of Agriculture. Veterinary Services, 1988.

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19

Bhatia, Neal, ed. Immunomodulators and Biologics in Dermatologic Treatment. Springer International Publishing, 2024. http://dx.doi.org/10.1007/978-3-031-66590-5.

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20

Cheifetz, Adam S., and Joseph D. Feuerstein, eds. Treatment of Inflammatory Bowel Disease with Biologics. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-60276-9.

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21

Moyer, Brian R., Narayan P. S. Cheruvu, and Tom C. C. Hu, eds. Pharmaco-Imaging in Drug and Biologics Development. Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4614-8247-5.

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22

van Vollenhoven, Ronald F. Biologics for the Treatment of Rheumatoid Arthritis. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-13108-5.

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23

United States. Biotechnology, Biologics, and Environmental Protection. Strategic plan: Biotechnology, biologics, and environmental protection. U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, 1989.

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24

Center for Drugs and Biologics (U.S.). Medical Library, ed. Center for Drugs and Biologics Medical Library. Medical Library, Center for Drugs and Biologics, U.S. Food and Drug Administration, 1987.

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25

Muttil, Pavan, and Nitesh K. Kunda, eds. Mucosal Delivery of Drugs and Biologics in Nanoparticles. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35910-2.

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26

Isenberg, David, and Angela Zink. Biologics registries. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0034.

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Double-blind controlled trials undertaken over the past two decades have established the short-term effectiveness and side-effect profile of biologic drugs for patients with rheumatoid arthritis and related diseases. However, the development of biologics registers to capture 'real-life experience' and explore long-term effectiveness and complications is equally important. In this chapter, we demonstrate how these registers have identified long-term joint benefits, a reduction in cardiovascular mortality, reassurance concerning fears about cancer development, and a balanced view of the risk of
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27

Isenberg, David, and Angela Zink. Biologics registries. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199642489.003.0034_update_001.

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Double-blind controlled trials undertaken over the past two decades have established the short-term effectiveness and side-effect profile of biologic drugs for patients with rheumatoid arthritis and related diseases. However, the development of biologics registers to capture ’real-life experience’ and explore long-term effectiveness and complications is equally important. In this chapter, we demonstrate how these registers have identified long-term joint benefits, a reduction in cardiovascular mortality, reassurance concerning fears about cancer development, and a balanced view of the risk of
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28

Braun, Juergen, and Irene E. van der Horst-Bruinsma. Treatment: biologics. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198734444.003.0022.

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According to classification criteria, the spectrum of spondyloarthritis (SpA) covers axial SpA (axSpA), which includes non-radiographic axSpA and ankylosing spondylitis, and peripheral SpA, which overlaps with psoriatic arthritis. Management recommendations for many forms of SpA have been recently published. Treatment of patients with axSpA with active disease starts with a sufficient dose of non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks and preferably longer, in combination with exercise. In case of peripheral SpA, several disease-modifying antirheumatic drugs can be giv
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29

Nonclinical Development of Biologics, Vaccines and Specialty Biologics. Elsevier Science & Technology, 2024.

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30

Committee on Health Education (senate), United States Senate, and United States United States Congress. Follow-On Biologics. Independently Published, 2019.

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31

Malhotra, Ashim, Catherine F. Yang, Xiaodong Feng, and Hong-Guang Xie. Biologics and Biosimilars. Taylor & Francis Group, 2022.

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32

Fuller, Claudette LaTonya, and Lisa Plitnick. Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics. Elsevier Science & Technology Books, 2024.

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33

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Elsevier, 2013. http://dx.doi.org/10.1016/c2011-0-07530-0.

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34

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. elsevier, 2013.

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35

Plitnick, Lisa, and Danuta Herzyk. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Elsevier Science & Technology Books, 2013.

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36

Developments in Biologicals: Biologics 2000 Comparability of Biotechnology Products. Karger, 2002.

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37

Puig, L., and W. Gulliver, eds. Adverse Reactions to Biologics. S. Karger AG, 2017. http://dx.doi.org/10.1159/isbn.978-3-318-06101-7.

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38

Grossman, Lewis. Drugs, Biologics, and Devices. Edited by I. Glenn Cohen, Allison K. Hoffman, and William M. Sage. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199366521.013.30.

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39

Niazi, Sarfaraz K. Biosimilars and Interchangeable Biologics. CRC Press, 2018. http://dx.doi.org/10.1201/b19161.

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40

Biologics in Orthopaedic Surgery. Elsevier, 2019. http://dx.doi.org/10.1016/c2016-0-05417-7.

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41

Niazi, Sarfaraz K. Biosimilars and Interchangeable Biologics. CRC Press, 2016. http://dx.doi.org/10.1201/b19077.

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42

Ramzan, Iqbal, ed. Biologics, Biosimilars, and Biobetters. Wiley, 2020. http://dx.doi.org/10.1002/9781119564690.

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43

Mazzocca, Augustus D., and Adam Lindsay. Biologics in Orthopaedic Surgery. Elsevier - Health Sciences Division, 2018.

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44

Biosimilars and Interchangeable Biologics. Taylor & Francis Group, 2023.

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45

(Editor), W. H. Boehncke, and H. H. Radeke (Editor), eds. Biologics in General Medicine. Springer, 2007.

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46

Top Biologics Companies - IMAPAC. IMAPAC, 2022.

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47

Stannard, James P., Lisa Ann Fortier, and James L. Cook. Biologics in Orthopaedic Surgery. Thieme Medical Publishers, Incorporated, 2015.

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48

Mazzocca, Augustus D., and Adam Lindsay. Biologics in Orthopaedic Surgery. Elsevier - Health Sciences Division, 2018.

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49

Hsu, Wellington K. Essentials of Spine Biologics. Taylor & Francis Group, 2023.

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50

Boehncke, W. H., and H. H. Radeke. Biologics in General Medicine. Springer, 2014.

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