메뉴 건너뛰기




Volumn 32, Issue 1, 2018, Pages 27-52

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY;

EID: 85040669431     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-017-0256-z     Document Type: Review
Times cited : (76)

References (134)
  • 1
    • 84955194105 scopus 로고    scopus 로고
    • Fc glycans of therapeutic antibodies as critical quality attributes
    • COI: 1:CAS:528:DC%2BC28Xhtlams7%2FJ, PID: 26263923
    • Reusch D, Tejada ML. Fc glycans of therapeutic antibodies as critical quality attributes. Glycobiology. 2015;25(12):1325–34.
    • (2015) Glycobiology. , vol.25 , Issue.12 , pp. 1325-1334
    • Reusch, D.1    Tejada, M.L.2
  • 2
    • 84904857984 scopus 로고    scopus 로고
    • Drift, evolution, and divergence in biologics and biosimilars manufacturing
    • PID: 24567263
    • Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28(4):363–72.
    • (2014) BioDrugs. , vol.28 , Issue.4 , pp. 363-372
    • Ramanan, S.1    Grampp, G.2
  • 4
    • 33644952525 scopus 로고    scopus 로고
    • Accessed 5 Sep 2015, European Medicines Agency
    • European Medicines Agency (EMA). Guideline on similar biological medicinal products. 2014. http://www.ema.europaeu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 5 Sep 2015.
    • (2014) Guideline on similar biological medicinal products.
  • 5
    • 85042334029 scopus 로고    scopus 로고
    • TGA)
    • Accessed 5 Sep 2016, Australian Therapeutic Goods Administration
    • Australian Therapeutic Goods Administration (TGA). Regulation of biosimilar medicines (Version 2.0, December 2015). https://www.tga.gov.au/sites/default/files/evaluation-biosimilars-151217_0.pdf. Accessed 5 Sep 2016.
    • Regulation of biosimilar medicines (Version 2.0, December 2015
  • 7
    • 85042264142 scopus 로고    scopus 로고
    • Accessed 8 Sep 2016, Australian Government Department of Health
    • Australian Government Department of Health. Biosimilar medicines—factsheet for healthcare professionals. 2016. http://www.pbs.gov.au/publication/factsheets/biosimilars/biosimilars-factsheet-healthcare-professionals.pdf. Accessed 8 Sep 2016.
    • (2016) Biosimilar medicines—factsheet for healthcare professionals
  • 8
    • 85042319562 scopus 로고    scopus 로고
    • Australian Pharmaceutical Benefits Scheme (PBS) Pharmaceutical Benefit Advisory Committee (PBAC)
    • Accessed 8 Sep 2016
    • Australian Pharmaceutical Benefits Scheme (PBS) Pharmaceutical Benefit Advisory Committee (PBAC). PBAC special meeting minutes. 2015. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2015-04/2015-04-biosimilars.pdf. Accessed 8 Sep 2016.
    • (2015) PBAC special meeting minutes.
  • 11
    • 85042302226 scopus 로고    scopus 로고
    • TGA)
    • Accessed 24 Oct 2017, Australian Therapeutic Goods Administration
    • Australian Therapeutic Goods Administration (TGA). Consultation: nomenclature of biological medicines (Version 1.0, July 2017). https://www.tga.gov.au/sites/default/files/consultation-nomenclature-biological-medicines.pdf. Accessed 24 Oct 2017.
    • Consultation: nomenclature of biological medicines (Version 1.0, July 2017
  • 12
    • 84943663241 scopus 로고    scopus 로고
    • Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases
    • COI: 1:CAS:528:DC%2BC2MXhs1Ohu73I, PID: 26365281
    • Papamichael K, Van Stappen T, Jairath V, Gecse K, Khanna R, D’Haens G, et al. Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Aliment Pharmacol Ther. 2015;42(10):1158–69.
    • (2015) Aliment Pharmacol Ther. , vol.42 , Issue.10 , pp. 1158-1169
    • Papamichael, K.1    Van Stappen, T.2    Jairath, V.3    Gecse, K.4    Khanna, R.5    D’Haens, G.6
  • 14
    • 84942293607 scopus 로고    scopus 로고
    • Biosimilar insulins: guidance for data interpretation by clinicians and users
    • COI: 1:CAS:528:DC%2BC2MXhsF2rur%2FN, PID: 25974131
    • Heinemann L, Home PD, Hompesch M. Biosimilar insulins: guidance for data interpretation by clinicians and users. Diabetes Obes Metab. 2015;17(10):911–8.
    • (2015) Diabetes Obes Metab. , vol.17 , Issue.10 , pp. 911-918
    • Heinemann, L.1    Home, P.D.2    Hompesch, M.3
  • 16
    • 85042308730 scopus 로고    scopus 로고
    • Interchangeability, switchability and substitution of biosimilar products
    • Endrenyi LDPJ, Chow SC, (eds), CRC Press/Taylor & Francis, London and New York
    • Declerck P, Endrenyi L, Chow SC. Interchangeability, switchability and substitution of biosimilar products. In: Endrenyi LDPJ, Chow SC, editors. Biosimilar drug product development. London and New York: CRC Press/Taylor & Francis; 2017.
    • (2017) Biosimilar drug product development
    • Declerck, P.1    Endrenyi, L.2    Chow, S.C.3
  • 17
    • 85010755037 scopus 로고    scopus 로고
    • Interchangeability of biosimilars: a European perspective
    • COI: 1:CAS:528:DC%2BC2sXhsFeitrY%3D, PID: 28120313
    • Kurki P, van Aerts L, Wolff-Holz E, Giezen T, Skibeli V, Weise M. Interchangeability of biosimilars: a European perspective. BioDrugs. 2017;31(2):83–91.
    • (2017) BioDrugs. , vol.31 , Issue.2 , pp. 83-91
    • Kurki, P.1    van Aerts, L.2    Wolff-Holz, E.3    Giezen, T.4    Skibeli, V.5    Weise, M.6
  • 18
    • 85042269810 scopus 로고    scopus 로고
    • Accessed 5 Sep 2016, US Food and Drug Administration
    • US Food and Drug Administration. Therapeutic biologic applications (BLA): information for industry (biosimilars). 2016. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241720.htm. Accessed 5 Sep 2016.
    • (2016) Therapeutic biologic applications (BLA): information for industry (biosimilars)
  • 20
    • 85042320367 scopus 로고    scopus 로고
    • Costs before caution—Australia’s unique approach to the interchangeability of
    • Accessed 8 Sep 2016
    • Allens Linklaters. Costs before caution—Australia’s unique approach to the interchangeability of biosimilars. 2016. http://www.allens.com.au/pubs/pdf/healthcare/BiosimilarsWhitePaper-CostsbeforeCaution.pdf. Accessed 8 Sep 2016.
    • (2016) biosimilars
    • Linklaters, A.1
  • 21
    • 84984596871 scopus 로고    scopus 로고
    • Clinical trials of biosimilars should become more similar
    • PID: 27566795
    • Kay J, Isaacs JD. Clinical trials of biosimilars should become more similar. Ann Rheum Dis. 2017;76(1):4–6.
    • (2017) Ann Rheum Dis. , vol.76 , Issue.1 , pp. 4-6
    • Kay, J.1    Isaacs, J.D.2
  • 22
    • 85042265959 scopus 로고    scopus 로고
    • American College of Rheumatology (ACR)
    • Accessed 11 Aug 2016
    • American College of Rheumatology (ACR). Position statement: biosimilars. 2016. http://www.rheumatology.org/Portals/0/Files/Biosimilars-Position-Statement.pdf. Accessed 11 Aug 2016.
    • (2016) Position statement: biosimilars.
  • 23
    • 85042254100 scopus 로고    scopus 로고
    • ADS) and Diabetes Australia and Australian Diabetes Educators Association (ADEA)
    • Accessed 5 Sep 2016, Australian Diabetes Society
    • Australian Diabetes Society (ADS) and Diabetes Australia and Australian Diabetes Educators Association (ADEA). 2015. Position statement: use of ‘biosimilar’ insulins for diabetes. https://diabetessociety.com.au/documents/BiosimilarSubstitutionPositionStatementDAADSADEATBFV20150911.pdf. Accessed 5 Sep 2016.
    • 2015. Position statement: use of ‘biosimilar’ insulins for diabetes
  • 24
    • 85042333256 scopus 로고    scopus 로고
    • ASCO policy brief: biosimilars
    • Accessed 5 Sep 2016, American Society of Clinical Oncology
    • American Society of Clinical Oncology. ASCO policy brief: biosimilars. 2015. https://www.asco.org/sites/new-wwwascoorg/files/content-files/advocacy-and-policy/documents/2013_biosilimars%20New.pdf. Accessed 5 Sep 2016.
    • (2015) ASCO policy brief: biosimilars.
  • 25
    • 85042303657 scopus 로고    scopus 로고
    • NRAS)
    • Accessed 5 Sep 2016, National Rheumatoid Arthritis Society
    • National Rheumatoid Arthritis Society (NRAS). NRAS position paper on biosimilars—revised June 2016. http://www.nras.org.uk/data/files/About%20RA/How%20is%20RA%20managed/NRAS%20Biosimilars%20Position%20Paper%20Final.pdf. Accessed 5 Sep 2016.
    • NRAS position paper on biosimilars—revised June 2016
  • 26
    • 85033346028 scopus 로고    scopus 로고
    • Accessed 6 Oct 2016
    • American Academy of Dermatology. Position paper on generic therapeutic & biosimilar substitution. 2013. https://www.aad.org/Forms/Policies/Uploads/PS/PS-Generic%20Therapeutic%20and%20%20Biosimilar%20Substitution.pdf. Accessed 6 Oct 2016.
    • (2013) Position paper on generic therapeutic & biosimilar substitution.
  • 27
    • 85019067891 scopus 로고    scopus 로고
    • Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers
    • PID: 28848668
    • Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017;1(6):e000142.
    • (2017) ESMO Open. , vol.1 , Issue.6
    • Tabernero, J.1    Vyas, M.2    Giuliani, R.3    Arnold, D.4    Cardoso, F.5    Casali, P.G.6
  • 28
    • 84908258298 scopus 로고    scopus 로고
    • Use of biosimilars in inflammatory bowel disease: statements of the Italian Group for Inflammatory Bowel Disease
    • PID: 25139379
    • Annese V, Vecchi M. Use of biosimilars in inflammatory bowel disease: statements of the Italian Group for Inflammatory Bowel Disease. Dig Liver Dis. 2014;46(11):963–8.
    • (2014) Dig Liver Dis. , vol.46 , Issue.11 , pp. 963-968
    • Annese, V.1    Vecchi, M.2
  • 29
    • 84898853424 scopus 로고    scopus 로고
    • The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper
    • PID: 24657898
    • Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I. The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014;13(7):751–5.
    • (2014) Autoimmun Rev. , vol.13 , Issue.7 , pp. 751-755
    • Fiorino, G.1    Girolomoni, G.2    Lapadula, G.3    Orlando, A.4    Danese, S.5    Olivieri, I.6
  • 31
    • 85008253096 scopus 로고    scopus 로고
    • Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses
    • Klein AV, Wang J, Bedford P. Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses. GaBi J. 2014;3(3):150–4.
    • (2014) GaBi J. , vol.3 , Issue.3 , pp. 150-154
    • Klein, A.V.1    Wang, J.2    Bedford, P.3
  • 32
    • 84885599208 scopus 로고    scopus 로고
    • Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics
    • PID: 24106727
    • Devlin SM, Bressler B, Bernstein CN, Fedorak RN, Bitton A, Singh H, et al. Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol. 2013;27(10):567–71.
    • (2013) Can J Gastroenterol. , vol.27 , Issue.10 , pp. 567-571
    • Devlin, S.M.1    Bressler, B.2    Bernstein, C.N.3    Fedorak, R.N.4    Bitton, A.5    Singh, H.6
  • 33
    • 85042318121 scopus 로고    scopus 로고
    • Gastroenterological Society of Australia (GESA) and Australian Inflammatory Bowel Disease Association (AIBDA)
    • Accessed 6 Oct 2016
    • Gastroenterological Society of Australia (GESA) and Australian Inflammatory Bowel Disease Association (AIBDA). GESA-AIBDA position on biosimilars substitution. 2015. http://www.gesa.org.au/files/editor_upload/File/NEWS/Position%20on%20Biosimilars%20GESA_AIBDA.pdf. Accessed 6 Oct 2016.
    • (2015) GESA-AIBDA position on biosimilars substitution.
  • 34
    • 85042271067 scopus 로고    scopus 로고
    • Accessed 6 Oct 2016
    • Arthritis Australia. Biosimilars and biologics: what you need to know. 2015. http://arthritisaustralia.com.au/indexphp/63-news/301-biosimilars-and-biologics-what-you-need-to-know.html. Accessed 6 Oct 2016.
    • (2015) Biosimilars and biologics: what you need to know.
  • 36
    • 84878624235 scopus 로고    scopus 로고
    • ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
    • PID: 23623738
    • Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7(7):586–9.
    • (2013) J Crohns Colitis. , vol.7 , Issue.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 37
    • 85042327646 scopus 로고    scopus 로고
    • Accessed 5 Sep 2016
    • European League Against Rheumatism (EULAR). Biosimilars: what do patients need to consider? 2015. http://www.eular.org/myUploadData/files/Biosimilars_2015.pdf. Accessed 5 Sep 2016.
    • (2015) Biosimilars: what do patients need to consider?
  • 38
    • 85042274419 scopus 로고    scopus 로고
    • Accessed 6 Oct 2016
    • Pharmaceutical Society of Australia. Biosimilar medicines: position statement. 2015. http://www.psa.org.au/downloads/ent/uploads/filebase/policies/biosimilar-medicines-position-statement.pdf. Accessed 6 Oct 2016.
    • (2015) Biosimilar medicines: position statement.
  • 39
    • 85042327724 scopus 로고    scopus 로고
    • Accessed 6 Oct 2016
    • The Pharmacy Guild of Australia. Policy: biosimilar medicines. 2015. https://www.guild.org.au/docs/default-source/public-documents/issues-and-resources/Policy-and-Position-Statements/20151026-guild-biosimilar-medicines.pdf?sfvrsn=0. Accessed 6 Oct 2016.
    • (2015) Policy: biosimilar medicines.
  • 40
    • 84962317965 scopus 로고    scopus 로고
    • Identification of low-level product-related variants in filgrastim products presently available in highly regulated markets
    • PID: 27026103
    • Hausberger A, Lamanna WC, Hartinger M, Seidl A, Toll H, Holzmann J. Identification of low-level product-related variants in filgrastim products presently available in highly regulated markets. BioDrugs. 2016;30(3):233–42.
    • (2016) BioDrugs. , vol.30 , Issue.3 , pp. 233-242
    • Hausberger, A.1    Lamanna, W.C.2    Hartinger, M.3    Seidl, A.4    Toll, H.5    Holzmann, J.6
  • 41
    • 85029825574 scopus 로고    scopus 로고
    • In-vivo biological activity and glycosylation analysis of a biosimilar recombinant human follicle-stimulating hormone product (Bemfola) compared with its reference medicinal product (GONAL-f)
    • PID: 28880909
    • Mastrangeli R, Satwekar A, Cutillo F, Ciampolillo C, Palinsky W, Longobardi S. In-vivo biological activity and glycosylation analysis of a biosimilar recombinant human follicle-stimulating hormone product (Bemfola) compared with its reference medicinal product (GONAL-f). PLoS One. 2017;12(9):e0184139.
    • (2017) PLoS One. , vol.12 , Issue.9
    • Mastrangeli, R.1    Satwekar, A.2    Cutillo, F.3    Ciampolillo, C.4    Palinsky, W.5    Longobardi, S.6
  • 42
    • 84937716098 scopus 로고    scopus 로고
    • The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control
    • COI: 1:CAS:528:DC%2BC2MXhtFKgtr3F, PID: 25998019
    • Bracewell DG, Francis R, Smales CM. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control. Biotechnol Bioeng. 2015;112(9):1727–37.
    • (2015) Biotechnol Bioeng. , vol.112 , Issue.9 , pp. 1727-1737
    • Bracewell, D.G.1    Francis, R.2    Smales, C.M.3
  • 43
    • 85016146498 scopus 로고    scopus 로고
    • Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
    • PID: 28331376
    • Abdalla A, Byrne N, Conway R, Walsh T, Mannion G, Hanly M, et al. Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product. Open Access Rheumatol. 2017;9:29–35.
    • (2017) Open Access Rheumatol. , vol.9 , pp. 29-35
    • Abdalla, A.1    Byrne, N.2    Conway, R.3    Walsh, T.4    Mannion, G.5    Hanly, M.6
  • 44
    • 85040585733 scopus 로고    scopus 로고
    • Early experience with biosimilar infliximab at a district general hospital for an entire Crohns disease patient cohort switch from Remicade to Inflectra
    • (abstract)
    • Ala K, Avery P, Wilson R, Prowse A, Shutt J, Jupp J, et al. Early experience with biosimilar infliximab at a district general hospital for an entire Crohns disease patient cohort switch from Remicade to Inflectra. Gut. 2016;65:A81 (abstract).
    • (2016) Gut. , vol.65 , pp. A81
    • Ala, K.1    Avery, P.2    Wilson, R.3    Prowse, A.4    Shutt, J.5    Jupp, J.6
  • 45
    • 85014667283 scopus 로고    scopus 로고
    • Effectiveness and safety of CT-P13 (biosimilar infliximab) in patients with inflammatory bowel disease in real life at 6 months
    • COI: 1:CAS:528:DC%2BC2sXktVGktbs%3D, PID: 28281165
    • Arguelles-Arias F, Guerra Veloz MF, Perea Amarillo R, Vilches-Arenas A, Castro Laria L, Maldonado Perez B, et al. Effectiveness and safety of CT-P13 (biosimilar infliximab) in patients with inflammatory bowel disease in real life at 6 months. Dig Dis Sci. 2017;62(5):1305–12.
    • (2017) Dig Dis Sci. , vol.62 , Issue.5 , pp. 1305-1312
    • Arguelles-Arias, F.1    Guerra Veloz, M.F.2    Perea Amarillo, R.3    Vilches-Arenas, A.4    Castro Laria, L.5    Maldonado Perez, B.6
  • 46
    • 85042261199 scopus 로고    scopus 로고
    • Prospective evaluation of the safety and efficacy of switching stable patients with inflammatory bowel disease from Remicade™ to biosimilar infliximab (IFX)
    • (abstract)
    • Bennett KJ, Heap GA, Hawkins S, Ahmad T. Prospective evaluation of the safety and efficacy of switching stable patients with inflammatory bowel disease from Remicade™ to biosimilar infliximab (IFX). Gut. 2016;65:A146 (abstract).
    • (2016) Gut. , vol.65 , pp. A146
    • Bennett, K.J.1    Heap, G.A.2    Hawkins, S.3    Ahmad, T.4
  • 47
    • 84979496968 scopus 로고    scopus 로고
    • Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study
    • COI: 1:CAS:528:DC%2BC28XhtlWgtbvL, PID: 27449503
    • Benucci M, Gobbi FL, Bandinelli F, Damiani A, Infantino M, Grossi V, et al. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study. Immunol Res. 2017;65(1):419–22.
    • (2017) Immunol Res. , vol.65 , Issue.1 , pp. 419-422
    • Benucci, M.1    Gobbi, F.L.2    Bandinelli, F.3    Damiani, A.4    Infantino, M.5    Grossi, V.6
  • 49
    • 84995578185 scopus 로고    scopus 로고
    • The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis
    • COI: 1:CAS:528:DC%2BC28Xht1ygsr7O, PID: 27473452
    • Dapavo P, Vujic I, Fierro MT, Quaglino P, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(4):736–9.
    • (2016) J Am Acad Dermatol. , vol.75 , Issue.4 , pp. 736-739
    • Dapavo, P.1    Vujic, I.2    Fierro, M.T.3    Quaglino, P.4    Sanlorenzo, M.5
  • 50
    • 85010905756 scopus 로고    scopus 로고
    • The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar
    • PID: 28092307
    • Fiorino G, Manetti N, Armuzzi A, Orlando A, Variola A, Bonovas S, et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis. 2017;23(2):233–43.
    • (2017) Inflamm Bowel Dis. , vol.23 , Issue.2 , pp. 233-243
    • Fiorino, G.1    Manetti, N.2    Armuzzi, A.3    Orlando, A.4    Variola, A.5    Bonovas, S.6
  • 51
    • 84976339013 scopus 로고    scopus 로고
    • Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases. Response to: Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–1683
    • Gentileschi S, Barreca C, Bellisai F, Biasi G, Brizi MG, De Stefano R, et al. Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases. Response to: Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–1683. Expert Opin Biol Ther. 2016:1–2.
    • (2016) Expert Opin Biol Ther , pp. 1-2
    • Gentileschi, S.1    Barreca, C.2    Bellisai, F.3    Biasi, G.4    Brizi, M.G.5    De Stefano, R.6
  • 52
    • 85020798557 scopus 로고    scopus 로고
    • A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry
    • PID: 28473425
    • Glintborg B, Sorensen IJ, Loft AG, Lindegaard H, Linauskas A, Hendricks O, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76:1426–31.
    • (2017) Ann Rheum Dis. , vol.76 , pp. 1426-1431
    • Glintborg, B.1    Sorensen, I.J.2    Loft, A.G.3    Lindegaard, H.4    Linauskas, A.5    Hendricks, O.6
  • 53
    • 85019086175 scopus 로고    scopus 로고
    • Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial
    • PID: 28502609
    • Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304–16.
    • (2017) Lancet. , vol.389 , Issue.10086 , pp. 2304-2316
    • Jorgensen, K.K.1    Olsen, I.C.2    Goll, G.L.3    Lorentzen, M.4    Bolstad, N.5    Haavardsholm, E.A.6
  • 54
    • 84940081554 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study
    • COI: 1:CAS:528:DC%2BC2MXhvFCqtr%2FF, PID: 25974251
    • Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30(12):1705–12.
    • (2015) J Gastroenterol Hepatol. , vol.30 , Issue.12 , pp. 1705-1712
    • Jung, Y.S.1    Park, D.I.2    Kim, Y.H.3    Lee, J.H.4    Seo, P.J.5    Cheon, J.H.6
  • 55
    • 84997745691 scopus 로고    scopus 로고
    • BOW015, a biosimilar infliximab: disease activity and disability outcomes from a phase 3 active comparator study in patients with active rheumatoid arthritis on stable methotrexate doses
    • (abstract)
    • Kay J, Chopra A, Lassen C, Shneyer L, Wyand M. BOW015, a biosimilar infliximab: disease activity and disability outcomes from a phase 3 active comparator study in patients with active rheumatoid arthritis on stable methotrexate doses. Ann Rheum Dis. 2015;74(Suppl 2):462–3 (abstract).
    • (2015) Ann Rheum Dis. , vol.74 , pp. 462-463
    • Kay, J.1    Chopra, A.2    Lassen, C.3    Shneyer, L.4    Wyand, M.5
  • 56
    • 84948710839 scopus 로고    scopus 로고
    • Safety profile of BOW015, a biosimilar infliximab, in healthy subjects and patients with active rheumatoid arthritis
    • (abstract)
    • Kay J, Lassen C, Trokan L, Wyand M. Safety profile of BOW015, a biosimilar infliximab, in healthy subjects and patients with active rheumatoid arthritis. Ann Rheum Dis. 2015;74(Suppl 2):706 (abstract).
    • (2015) Ann Rheum Dis. , vol.74 , pp. 706
    • Kay, J.1    Lassen, C.2    Trokan, L.3    Wyand, M.4
  • 57
    • 85011715913 scopus 로고    scopus 로고
    • Infliximab biosimilar (Remsima) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre
    • COI: 1:STN:280:DC%2BC1c3hslaktg%3D%3D, PID: 28147356
    • Kolar M, Duricova D, Bortlik M, Hruba V, Machkova N, Mitrova K, et al. Infliximab biosimilar (Remsima) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre. Dig Dis. 2017;35(1–2):91–100.
    • (2017) Dig Dis. , vol.35 , Issue.1-2 , pp. 91-100
    • Kolar, M.1    Duricova, D.2    Bortlik, M.3    Hruba, V.4    Machkova, N.5    Mitrova, K.6
  • 58
    • 84946601256 scopus 로고    scopus 로고
    • Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
    • COI: 1:CAS:528:DC%2BC2MXhvVSltL3N, PID: 26549204
    • Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15(12):1677–83.
    • (2015) Expert Opin Biol Ther. , vol.15 , Issue.12 , pp. 1677-1683
    • Nikiphorou, E.1    Kautiainen, H.2    Hannonen, P.3    Asikainen, J.4    Kokko, A.5    Rannio, T.6
  • 59
    • 84942325078 scopus 로고    scopus 로고
    • Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
    • PID: 26395533
    • Park SH, Kim YH, Lee JH, Kwon HJ, Lee SH, Park DI, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl 1):35–44.
    • (2015) Expert Rev Gastroenterol Hepatol. , vol.9 , pp. 35-44
    • Park, S.H.1    Kim, Y.H.2    Lee, J.H.3    Kwon, H.J.4    Lee, S.H.5    Park, D.I.6
  • 60
    • 85020658439 scopus 로고    scopus 로고
    • Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: results of a 56-week open-label study in patients with rheumatoid arthritis
    • COI: 1:CAS:528:DC%2BC2sXpslWht7w%3D, PID: 28600696
    • Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, et al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: results of a 56-week open-label study in patients with rheumatoid arthritis. BioDrugs. 2017;31(4):369–77.
    • (2017) BioDrugs. , vol.31 , Issue.4 , pp. 369-377
    • Park, W.1    Suh, C.H.2    Shim, S.C.3    Molina, F.F.C.4    Jeka, S.5    Medina-Rodriguez, F.G.6
  • 61
    • 84965014483 scopus 로고    scopus 로고
    • Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study
    • PID: 27117698
    • Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76:346–54.
    • (2017) Ann Rheum Dis. , vol.76 , pp. 346-354
    • Park, W.1    Yoo, D.H.2    Miranda, P.3    Brzosko, M.4    Wiland, P.5    Gutierrez-Urena, S.6
  • 62
    • 85042306625 scopus 로고    scopus 로고
    • In patients with IBD switching from originator infliximab (Remicade) to biosimilar infliximab (CT-P13) is safe and effective
    • (abstract)
    • Rahmany S, Cotton S, Garnish S, Brown M, Saich R, Lloyd D, et al. In patients with IBD switching from originator infliximab (Remicade) to biosimilar infliximab (CT-P13) is safe and effective. Gut. 2016;65:A89 (abstract).
    • (2016) Gut. , vol.65 , pp. A89
    • Rahmany, S.1    Cotton, S.2    Garnish, S.3    Brown, M.4    Saich, R.5    Lloyd, D.6
  • 63
    • 85019131687 scopus 로고    scopus 로고
    • Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme
    • PID: 28130330
    • Razanskaite V, Bettey M, Downey L, Wright J, Callaghan J, Rush M, et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme. J Crohns Colitis. 2017;11(6):690–6.
    • (2017) J Crohns Colitis. , vol.11 , Issue.6 , pp. 690-696
    • Razanskaite, V.1    Bettey, M.2    Downey, L.3    Wright, J.4    Callaghan, J.5    Rush, M.6
  • 65
    • 85016144717 scopus 로고    scopus 로고
    • Preliminary data on the introduction of the infliximab biosimilar (CT-P13) to a real world cohort of rheumatology patients
    • (abstract)
    • Sheppard M, Hadavi S, Hayes F, Kent J, Dasgupta B. Preliminary data on the introduction of the infliximab biosimilar (CT-P13) to a real world cohort of rheumatology patients. Ann Rheum Dis. 2016;75(Suppl 2):1011 (abstract).
    • (2016) Ann Rheum Dis. , vol.75 , pp. 1011
    • Sheppard, M.1    Hadavi, S.2    Hayes, F.3    Kent, J.4    Dasgupta, B.5
  • 66
    • 85011663828 scopus 로고    scopus 로고
    • Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations
    • COI: 1:STN:280:DC%2BC28rmtlOjtw%3D%3D, PID: 26721942
    • Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10(2):127–32.
    • (2016) J Crohns Colitis. , vol.10 , Issue.2 , pp. 127-132
    • Sieczkowska, J.1    Jarzebicka, D.2    Banaszkiewicz, A.3    Plocek, A.4    Gawronska, A.5    Toporowska-Kowalska, E.6
  • 67
    • 85020284797 scopus 로고    scopus 로고
    • Therapeutic drug monitoring (TDM) as a tool in the switch from infliximab innovator to biosimilar in rheumatic patients: results of a 12-month observational prospective cohort study
    • COI: 1:STN:280:DC%2BC1cnmt1aiug%3D%3D, PID: 28593609
    • Schmitz EMH, Benoy-De Keuster S, Meier AJL, Scharnhorst V, Traksel RAM, Broeren MAC, et al. Therapeutic drug monitoring (TDM) as a tool in the switch from infliximab innovator to biosimilar in rheumatic patients: results of a 12-month observational prospective cohort study. Clin Rheumatol. 2017;36(9):2129–34.
    • (2017) Clin Rheumatol. , vol.36 , Issue.9 , pp. 2129-2134
    • Schmitz, E.M.H.1    Benoy-De Keuster, S.2    Meier, A.J.L.3    Scharnhorst, V.4    Traksel, R.A.M.5    Broeren, M.A.C.6
  • 69
    • 85017017931 scopus 로고    scopus 로고
    • Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study
    • (abstract)
    • Smolen JS, Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study. Ann Rheum Dis. 2016;75(Suppl 2):488 (abstract).
    • (2016) Ann Rheum Dis. , vol.75 , pp. 488
    • Smolen, J.S.1    Choe, J.-Y.2    Prodanovic, N.3    Niebrzydowski, J.4    Staykov, I.5    Dokoupilova, E.6
  • 70
    • 84984714652 scopus 로고    scopus 로고
    • Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab
    • COI: 1:CAS:528:DC%2BC28XhsV2hsLnO, PID: 27586879
    • Tanaka Y, Yamanaka H, Takeuchi T, Inoue M, Saito K, Saeki Y, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2017;27(2):237–45.
    • (2017) Mod Rheumatol. , vol.27 , Issue.2 , pp. 237-245
    • Tanaka, Y.1    Yamanaka, H.2    Takeuchi, T.3    Inoue, M.4    Saito, K.5    Saeki, Y.6
  • 71
    • 85042298385 scopus 로고    scopus 로고
    • Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice
    • (abstract)
    • Tweehuysen L, Van Den Bemt BJF, Van Ingen IL, De Jong AJL, Van Der Laan WH, Van Den Hoogen FHJ, et al. Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice. Arthritis Rheumatol. 2016;68:821–3 (abstract).
    • (2016) Arthritis Rheumatol. , vol.68 , pp. 821-823
    • Tweehuysen, L.1    Van Den Bemt, B.J.F.2    Van Ingen, I.L.3    De Jong, A.J.L.4    Van Der Laan, W.H.5    Van Den Hoogen, F.H.J.6
  • 72
    • 85021197245 scopus 로고    scopus 로고
    • A descriptive analysis of real-world treatment patterns in a Turkish rheumatology population that continued innovator infliximab (Remicade) therapy or switched to biosimilar infliximab
    • (abstract)
    • Yazici Y, Xie L, Ogbomo A, Parenti D, Goyal K, Teeple A, et al. A descriptive analysis of real-world treatment patterns in a Turkish rheumatology population that continued innovator infliximab (Remicade) therapy or switched to biosimilar infliximab. Arthritis Rheumatol. 2016;68:2903–6 (abstract).
    • (2016) Arthritis Rheumatol. , vol.68 , pp. 2903-2906
    • Yazici, Y.1    Xie, L.2    Ogbomo, A.3    Parenti, D.4    Goyal, K.5    Teeple, A.6
  • 73
    • 84966417145 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
    • PID: 27130908
    • Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76:355–63.
    • (2017) Ann Rheum Dis. , vol.76 , pp. 355-363
    • Yoo, D.H.1    Prodanovic, N.2    Jaworski, J.3    Miranda, P.4    Ramiterre, E.5    Lanzon, A.6
  • 74
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • COI: 1:CAS:528:DC%2BD1MXhs1WisrfL, PID: 19863881
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009;72(5):380–90.
    • (2009) Clin Nephrol. , vol.72 , Issue.5 , pp. 380-390
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 76
    • 84876736657 scopus 로고    scopus 로고
    • A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia
    • PID: 23052412
    • Hörbrand F, Bramlage P, Fischaleck J, Hasford J, Brunkhorst R. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol. 2013;69(4):929–36.
    • (2013) Eur J Clin Pharmacol. , vol.69 , Issue.4 , pp. 929-936
    • Hörbrand, F.1    Bramlage, P.2    Fischaleck, J.3    Hasford, J.4    Brunkhorst, R.5
  • 78
    • 84957615076 scopus 로고    scopus 로고
    • Dosing penalty of erythropoiesis-stimulating agents after switching from originator to biosimilar preparations in stable hemodialysis patients
    • PID: 26879099
    • Minutolo R, Borzumati M, Sposini S, Abaterusso C, Carraro G, Santoboni A, et al. Dosing penalty of erythropoiesis-stimulating agents after switching from originator to biosimilar preparations in stable hemodialysis patients. Am J Kidney Dis. 2016;68(1):170–2.
    • (2016) Am J Kidney Dis. , vol.68 , Issue.1 , pp. 170-172
    • Minutolo, R.1    Borzumati, M.2    Sposini, S.3    Abaterusso, C.4    Carraro, G.5    Santoboni, A.6
  • 80
    • 84887950120 scopus 로고    scopus 로고
    • Efficacy of once or twice weekly administration of epoetin kappa in patients receiving hemodialysis: a retrospective study
    • COI: 1:CAS:528:DC%2BC2cXjs1Khsbw%3D, PID: 24348759
    • Ohta S, Yasuno N, Inomoto Y, Matsuda K, Nakagawa Y, Sasagawa I, et al. Efficacy of once or twice weekly administration of epoetin kappa in patients receiving hemodialysis: a retrospective study. Exp Ther Med. 2014;7(1):27–30.
    • (2014) Exp Ther Med. , vol.7 , Issue.1 , pp. 27-30
    • Ohta, S.1    Yasuno, N.2    Inomoto, Y.3    Matsuda, K.4    Nakagawa, Y.5    Sasagawa, I.6
  • 81
    • 79251633136 scopus 로고    scopus 로고
    • Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis
    • PID: 20972656
    • Wiecek A, Ahmed I, Scigalla P, Koytchev R. Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis. Adv Ther. 2010;27(12):941–52.
    • (2010) Adv Ther. , vol.27 , Issue.12 , pp. 941-952
    • Wiecek, A.1    Ahmed, I.2    Scigalla, P.3    Koytchev, R.4
  • 82
    • 41149131276 scopus 로고    scopus 로고
    • Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment
    • COI: 1:CAS:528:DC%2BD1cXkvValtb4%3D, PID: 18208642
    • Wizemann V, Rutkowski B, Baldamus C, Scigalla P, Koytchev R. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008;24(3):625–37.
    • (2008) Curr Med Res Opin. , vol.24 , Issue.3 , pp. 625-637
    • Wizemann, V.1    Rutkowski, B.2    Baldamus, C.3    Scigalla, P.4    Koytchev, R.5
  • 83
    • 85042294832 scopus 로고    scopus 로고
    • Shifting to biosimilar insulin preparation: impact on glycemic control and cost
    • 36:abstract THR-659
    • Balili CAV, Mendoza ESR, Mercado-Asis LB. Shifting to biosimilar insulin preparation: impact on glycemic control and cost. Endocrine Reviews. 2015;36:abstract THR-659.
    • (2015) Endocrine Reviews.
    • Balili, C.A.V.1    Mendoza, E.S.R.2    Mercado-Asis, L.B.3
  • 84
    • 84959919994 scopus 로고    scopus 로고
    • Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine
    • COI: 1:CAS:528:DC%2BC28XjvFGhtbg%3D, PID: 26749289
    • Hadjiyianni I, Dahl D, Lacaya LB, Pollom RK, Chang CL, Ilag LL. Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine. Diabetes Obes Metab. 2016;18(4):425–9.
    • (2016) Diabetes Obes Metab. , vol.18 , Issue.4 , pp. 425-429
    • Hadjiyianni, I.1    Dahl, D.2    Lacaya, L.B.3    Pollom, R.K.4    Chang, C.L.5    Ilag, L.L.6
  • 85
    • 84956873259 scopus 로고    scopus 로고
    • Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus(R) insulin glargine in patients with type 1 or type 2 diabetes mellitus
    • COI: 1:CAS:528:DC%2BC28Xhs1Kiu7g%3D, PID: 26434665
    • Ilag LL, Deeg MA, Costigan T, Hollander P, Blevins TC, Edelman SV, et al. Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus(R) insulin glargine in patients with type 1 or type 2 diabetes mellitus. Diabetes Obes Metab. 2016;18(2):159–68.
    • (2016) Diabetes Obes Metab. , vol.18 , Issue.2 , pp. 159-168
    • Ilag, L.L.1    Deeg, M.A.2    Costigan, T.3    Hollander, P.4    Blevins, T.C.5    Edelman, S.V.6
  • 86
    • 84937817049 scopus 로고    scopus 로고
    • Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus(R)) in patients with type 2 diabetes who were insulin-naive or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study)
    • COI: 1:CAS:528:DC%2BC2MXht1KrsrnI, PID: 25931141
    • Rosenstock J, Hollander P, Bhargava A, Ilag LL, Pollom RK, Zielonka JS, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus(R)) in patients with type 2 diabetes who were insulin-naive or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17(8):734–41.
    • (2015) Diabetes Obes Metab. , vol.17 , Issue.8 , pp. 734-741
    • Rosenstock, J.1    Hollander, P.2    Bhargava, A.3    Ilag, L.L.4    Pollom, R.K.5    Zielonka, J.S.6
  • 87
    • 84879475098 scopus 로고    scopus 로고
    • The Biosulin equivalence in standard therapy (BEST) study—a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus
    • COI: 1:STN:280:DC%2BC3sjlvFKhuw%3D%3D, PID: 23802207
    • Segal D, Tupy D, Distiller L. The Biosulin equivalence in standard therapy (BEST) study—a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus. S Afr Med J. 2013;103(7):458–60.
    • (2013) S Afr Med J. , vol.103 , Issue.7 , pp. 458-460
    • Segal, D.1    Tupy, D.2    Distiller, L.3
  • 88
    • 84918518708 scopus 로고    scopus 로고
    • Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden
    • PID: 24392303
    • Flodmark CE, Lilja K, Woehling H, Jarvholm K. Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden. Biol Ther. 2013;3:35–43.
    • (2013) Biol Ther. , vol.3 , pp. 35-43
    • Flodmark, C.E.1    Lilja, K.2    Woehling, H.3    Jarvholm, K.4
  • 89
    • 85042259235 scopus 로고    scopus 로고
    • ®: an experience of a single paediatric centre in Spain
    • (abstract)
    • ®: an experience of a single paediatric centre in Spain. Horm Res Paediatr. 2014;82:414 (abstract).
    • (2014) Horm Res Paediatr. , vol.82 , pp. 414
    • Gila, A.G.1    Garcia, M.P.2
  • 90
    • 84978817333 scopus 로고    scopus 로고
    • ® from other recombinant human growth hormone therapies: a retrospective study in an integrated healthcare system
    • PID: 25096555
    • ® from other recombinant human growth hormone therapies: a retrospective study in an integrated healthcare system. Biol Ther. 2014;4(1–2):27–39.
    • (2014) Biol Ther. , vol.4 , Issue.1-2 , pp. 27-39
    • Rashid, N.1    Saenger, P.2    Wu, Y.L.3    Woehling, H.4    Frankel, M.5    Lifshitz, F.6
  • 91
    • 84937022739 scopus 로고    scopus 로고
    • Assessing switchability for biosimilar products: modelling approaches applied to children’s growth
    • PID: 25989222
    • Belleli R, Fisch R, Renard D, Woehling H, Gsteiger S. Assessing switchability for biosimilar products: modelling approaches applied to children’s growth. Pharm Stat. 2015;14(4):341–9.
    • (2015) Pharm Stat. , vol.14 , Issue.4 , pp. 341-349
    • Belleli, R.1    Fisch, R.2    Renard, D.3    Woehling, H.4    Gsteiger, S.5
  • 92
    • 84898803216 scopus 로고    scopus 로고
    • Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data
    • PID: 24392295
    • Romer T, Zabransky M, Walczak M, Szalecki M, Balser S. Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data. Biol Ther. 2011;1:5.
    • (2011) Biol Ther. , vol.1 , pp. 5
    • Romer, T.1    Zabransky, M.2    Walczak, M.3    Szalecki, M.4    Balser, S.5
  • 93
    • 67650879442 scopus 로고    scopus 로고
    • XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy
    • COI: 1:CAS:528:DC%2BD1MXktVKit7s%3D, PID: 19347726
    • Engert A, Griskevicius L, Zyuzgin Y, Lubenau H, del Giglio A. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma. 2009;50(3):374–9.
    • (2009) Leuk Lymphoma. , vol.50 , Issue.3 , pp. 374-379
    • Engert, A.1    Griskevicius, L.2    Zyuzgin, Y.3    Lubenau, H.4    del Giglio, A.5
  • 94
    • 67849119891 scopus 로고    scopus 로고
    • XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy
    • PID: 19404210
    • Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, Del Giglio A. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. J Thorac Oncol. 2009;4(6):736–40.
    • (2009) J Thorac Oncol. , vol.4 , Issue.6 , pp. 736-740
    • Gatzemeier, U.1    Ciuleanu, T.2    Dediu, M.3    Ganea-Motan, E.4    Lubenau, H.5    Del Giglio, A.6
  • 95
    • 85042322500 scopus 로고    scopus 로고
    • Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim for the prevention of severe neutropenia, in patients with breast cancer receiving myelosuppressive chemotherapy
    • (abstract)
    • Krendyukov A, Harbeck N, Gascon P, Gattu S, Li Y, Blackwell KL. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim for the prevention of severe neutropenia, in patients with breast cancer receiving myelosuppressive chemotherapy. J Clin Oncol. 2017;35:abstr10116 (abstract).
    • (2017) J Clin Oncol. , vol.35 , pp. abstr10116
    • Krendyukov, A.1    Harbeck, N.2    Gascon, P.3    Gattu, S.4    Li, Y.5    Blackwell, K.L.6
  • 96
    • 85042259128 scopus 로고    scopus 로고
    • Single transition from adalimumab to ABP 501: evaluation of immunogenicity in a phase 3 study in subjects with moderate to severe plaque psoriasis
    • (abstract)
    • Gooderham M, Spelman L, Kaliaperumal A, Costanzo A, Narbutt J, Zhang N, et al. Single transition from adalimumab to ABP 501: evaluation of immunogenicity in a phase 3 study in subjects with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;74(5):AB275 (abstract).
    • (2016) J Am Acad Dermatol. , vol.74 , Issue.5 , pp. AB275
    • Gooderham, M.1    Spelman, L.2    Kaliaperumal, A.3    Costanzo, A.4    Narbutt, J.5    Zhang, N.6
  • 97
    • 85014763807 scopus 로고    scopus 로고
    • Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study
    • COI: 1:CAS:528:DC%2BC2sXktlSiu7k%3D, PID: 28291552
    • Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017;76(6):1093–102.
    • (2017) J Am Acad Dermatol. , vol.76 , Issue.6 , pp. 1093-1102
    • Papp, K.1    Bachelez, H.2    Costanzo, A.3    Foley, P.4    Gooderham, M.5    Kaur, P.6
  • 99
    • 85013244231 scopus 로고    scopus 로고
    • Interchangeability of innovator rituximab and its biosimilar: results from international controlled comparative 1-year study in patients with active rheumatoid arthritis
    • Nasonov E, Mazurov V, Plaksina T, Nesmeyanova O, Knyazeva L, Eremeeva A, et al. Interchangeability of innovator rituximab and its biosimilar: results from international controlled comparative 1-year study in patients with active rheumatoid arthritis. Arthritis Rheumatol. 2016;68:2046–7.
    • (2016) Arthritis Rheumatol. , vol.68 , pp. 2046-2047
    • Nasonov, E.1    Mazurov, V.2    Plaksina, T.3    Nesmeyanova, O.4    Knyazeva, L.5    Eremeeva, A.6
  • 100
    • 84893326421 scopus 로고    scopus 로고
    • Comparison of the efficacy and safety of rituximab (Mabthera) and its biosimilar (Reditux) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: a retrospective analysis
    • PID: 24604960
    • Roy PS, John S, Karankal S, Kannan S, Pawaskar P, Gawande J, et al. Comparison of the efficacy and safety of rituximab (Mabthera) and its biosimilar (Reditux) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: a retrospective analysis. Indian J Med Paediatr Oncol. 2013;34(4):292–8.
    • (2013) Indian J Med Paediatr Oncol. , vol.34 , Issue.4 , pp. 292-298
    • Roy, P.S.1    John, S.2    Karankal, S.3    Kannan, S.4    Pawaskar, P.5    Gawande, J.6
  • 102
    • 85013300383 scopus 로고    scopus 로고
    • Long-term safety and efficacy of SB4 (etanercept biosimilar) in patients with rheumatoid arthritis: comparison between continuing SB4 and switching from etanercept reference product to SB4
    • (abstract)
    • Emery P, Vencovsky J, Sylwestrzak P, Leszczynski P, Porawska W, Stasiuk B, et al. Long-term safety and efficacy of SB4 (etanercept biosimilar) in patients with rheumatoid arthritis: comparison between continuing SB4 and switching from etanercept reference product to SB4. Ann Rheum Dis. 2016;75(Suppl 2):236 (abstract).
    • (2016) Ann Rheum Dis. , vol.75 , pp. 236
    • Emery, P.1    Vencovsky, J.2    Sylwestrzak, P.3    Leszczynski, P.4    Porawska, W.5    Stasiuk, B.6
  • 103
    • 85014009195 scopus 로고    scopus 로고
    • The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis
    • COI: 1:CAS:528:DC%2BC2sXmtFCltb0%3D, PID: 27787890
    • Griffiths CEM, Thaci D, Gerdes S, Arenberger P, Pulka G, Kingo K, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176(4):928–38.
    • (2017) Br J Dermatol. , vol.176 , Issue.4 , pp. 928-938
    • Griffiths, C.E.M.1    Thaci, D.2    Gerdes, S.3    Arenberger, P.4    Pulka, G.5    Kingo, K.6
  • 104
    • 84976884442 scopus 로고    scopus 로고
    • ® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to main study
    • PID: 27287439
    • ® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to main study. Reprod Biol Endocrinol. 2016;14(1):31.
    • (2016) Reprod Biol Endocrinol. , vol.14 , Issue.1 , pp. 31
    • Strowitzki, T.1    Kuczynski, W.2    Mueller, A.3    Bias, P.4
  • 105
    • 85042312418 scopus 로고    scopus 로고
    • Non-medical switch from originator to biosimilar infliximab among patients with inflammatory rheumatic disease—impact on S-infliximab and antidrug-antibodies. Results from the National Danish Rheumatologic Biobank and the Danbio Registry
    • (abstract)
    • Glintborg B, Kringelbach T, Hogdall E, Sorensen IJ, Jensen DV, Loft AG, et al. Non-medical switch from originator to biosimilar infliximab among patients with inflammatory rheumatic disease—impact on S-infliximab and antidrug-antibodies. Results from the National Danish Rheumatologic Biobank and the Danbio Registry. Ann Rheum Dis. 2016;75(Suppl 2):224 (abstract).
    • (2016) Ann Rheum Dis. , vol.75 , pp. 224
    • Glintborg, B.1    Kringelbach, T.2    Hogdall, E.3    Sorensen, I.J.4    Jensen, D.V.5    Loft, A.G.6
  • 106
    • 79953906254 scopus 로고    scopus 로고
    • Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up
    • COI: 1:CAS:528:DC%2BC3MXkvFeitrY%3D, PID: 21486979
    • Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305(14):1460–8.
    • (2011) JAMA. , vol.305 , Issue.14 , pp. 1460-1468
    • Bartelds, G.M.1    Krieckaert, C.L.2    Nurmohamed, M.T.3    van Schouwenburg, P.A.4    Lems, W.F.5    Twisk, J.W.6
  • 107
    • 79960935860 scopus 로고    scopus 로고
    • Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis
    • COI: 1:CAS:528:DC%2BC3MXptFCltb8%3D, PID: 21427177
    • Pascual-Salcedo D, Plasencia C, Ramiro S, Nuno L, Bonilla G, Nagore D, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford). 2011;50(8):1445–52.
    • (2011) Rheumatology (Oxford). , vol.50 , Issue.8 , pp. 1445-1452
    • Pascual-Salcedo, D.1    Plasencia, C.2    Ramiro, S.3    Nuno, L.4    Bonilla, G.5    Nagore, D.6
  • 108
    • 84941425844 scopus 로고    scopus 로고
    • Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases
    • COI: 1:CAS:528:DC%2BC2MXhtlOms73J, PID: 26280210
    • Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysis. BioDrugs. 2015;29(4):241–58.
    • (2015) A systematic review and meta-analysis. BioDrugs. , vol.29 , Issue.4 , pp. 241-258
    • Thomas, S.S.1    Borazan, N.2    Barroso, N.3    Duan, L.4    Taroumian, S.5    Kretzmann, B.6
  • 109
    • 84970968764 scopus 로고    scopus 로고
    • Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications
    • COI: 1:STN:280:DC%2BC28bhslOqug%3D%3D, PID: 27097592
    • Dowlat HA, Kuhlmann MK, Khatami H, Ampudia-Blasco FJ. Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications. Diabetes Obes Metab. 2016;18(8):737–46.
    • (2016) Diabetes Obes Metab. , vol.18 , Issue.8 , pp. 737-746
    • Dowlat, H.A.1    Kuhlmann, M.K.2    Khatami, H.3    Ampudia-Blasco, F.J.4
  • 111
    • 85026497762 scopus 로고    scopus 로고
    • Market watch: strategies for biosimilars in emerging markets
    • COI: 1:CAS:528:DC%2BC2sXhtFelsLrK, PID: 28685764
    • Gautam A. Market watch: strategies for biosimilars in emerging markets. Nat Rev Drug Discov. 2017;16(8):520–1.
    • (2017) Nat Rev Drug Discov. , vol.16 , Issue.8 , pp. 520-521
    • Gautam, A.1
  • 112
    • 84965081890 scopus 로고    scopus 로고
    • How did the introduction of biosimilar filgrastim influence the prescribing pattern of granulocyte colony-stimulating factors? Results from a multicentre, population-based study, from five Italian centres in the years 2009–2014
    • COI: 1:CAS:528:DC%2BC28XnsVegtro%3D, PID: 27138636
    • Marciano I, Ingrasciotta Y, Giorgianni F, Bolcato J, Chinellato A, Pirolo R, et al. How did the introduction of biosimilar filgrastim influence the prescribing pattern of granulocyte colony-stimulating factors? Results from a multicentre, population-based study, from five Italian centres in the years 2009–2014. BioDrugs. 2016;30(4):295–306.
    • (2016) BioDrugs. , vol.30 , Issue.4 , pp. 295-306
    • Marciano, I.1    Ingrasciotta, Y.2    Giorgianni, F.3    Bolcato, J.4    Chinellato, A.5    Pirolo, R.6
  • 113
    • 84941346467 scopus 로고    scopus 로고
    • How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009–2013
    • PID: 26169209
    • Ingrasciotta Y, Giorgianni F, Bolcato J, Chinellato A, Pirolo R, Tari DU, et al. How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009–2013. BioDrugs. 2015;29(4):275–84.
    • (2015) BioDrugs. , vol.29 , Issue.4 , pp. 275-284
    • Ingrasciotta, Y.1    Giorgianni, F.2    Bolcato, J.3    Chinellato, A.4    Pirolo, R.5    Tari, D.U.6
  • 115
    • 84934767258 scopus 로고    scopus 로고
    • Pharmacist substitution of biological products: issues and considerations
    • PID: 26108377
    • Li E, Ramanan S, Green L. Pharmacist substitution of biological products: issues and considerations. J Manag Care Spec Pharm. 2015;21(7):532–9.
    • (2015) J Manag Care Spec Pharm. , vol.21 , Issue.7 , pp. 532-539
    • Li, E.1    Ramanan, S.2    Green, L.3
  • 116
    • 84903584733 scopus 로고    scopus 로고
    • Glycosylation affirmed as quality metric
    • DePalma A. Glycosylation affirmed as quality metric. GEN Select. 2014;34(13):5263.
    • (2014) GEN Select , vol.34 , Issue.13 , pp. 5263
    • DePalma, A.1
  • 117
    • 84860911340 scopus 로고    scopus 로고
    • Quantitative evaluation of fucose reducing effects in a humanized antibody on Fcgamma receptor binding and antibody-dependent cell-mediated cytotoxicity activities
    • PID: 22531441
    • Chung S, Quarmby V, Gao X, Ying Y, Lin L, Reed C, et al. Quantitative evaluation of fucose reducing effects in a humanized antibody on Fcgamma receptor binding and antibody-dependent cell-mediated cytotoxicity activities. MAbs. 2012;4(3):326–40.
    • (2012) MAbs. , vol.4 , Issue.3 , pp. 326-340
    • Chung, S.1    Quarmby, V.2    Gao, X.3    Ying, Y.4    Lin, L.5    Reed, C.6
  • 118
    • 33845590523 scopus 로고    scopus 로고
    • Comparison of biological activity among nonfucosylated therapeutic IgG1 antibodies with three different N-linked Fc oligosaccharides: the high-mannose, hybrid, and complex types
    • COI: 1:CAS:528:DC%2BD28XhtlChtbrK, PID: 17012310
    • Kanda Y, Yamada T, Mori K, Okazaki A, Inoue M, Kitajima-Miyama K, et al. Comparison of biological activity among nonfucosylated therapeutic IgG1 antibodies with three different N-linked Fc oligosaccharides: the high-mannose, hybrid, and complex types. Glycobiology. 2007;17(1):104–18.
    • (2007) Glycobiology. , vol.17 , Issue.1 , pp. 104-118
    • Kanda, Y.1    Yamada, T.2    Mori, K.3    Okazaki, A.4    Inoue, M.5    Kitajima-Miyama, K.6
  • 119
    • 77955412238 scopus 로고    scopus 로고
    • Post-translational modifications differentially affect IgG1 conformation and receptor binding
    • COI: 1:CAS:528:DC%2BC3cXhtlWgtbrM, PID: 20103567
    • Houde D, Peng Y, Berkowitz SA, Engen JR. Post-translational modifications differentially affect IgG1 conformation and receptor binding. Mol Cell Proteomics. 2010;9(8):1716–28.
    • (2010) Mol Cell Proteomics. , vol.9 , Issue.8 , pp. 1716-1728
    • Houde, D.1    Peng, Y.2    Berkowitz, S.A.3    Engen, J.R.4
  • 120
    • 84863440630 scopus 로고    scopus 로고
    • Production, characterization, and pharmacokinetic properties of antibodies with N-linked mannose-5 glycans
    • PID: 22699308
    • Yu M, Brown D, Reed C, Chung S, Lutman J, Stefanich E, et al. Production, characterization, and pharmacokinetic properties of antibodies with N-linked mannose-5 glycans. MAbs. 2012;4(4):475–87.
    • (2012) MAbs. , vol.4 , Issue.4 , pp. 475-487
    • Yu, M.1    Brown, D.2    Reed, C.3    Chung, S.4    Lutman, J.5    Stefanich, E.6
  • 121
    • 0034949634 scopus 로고    scopus 로고
    • Development and characterization of novel erythropoiesis stimulating protein (NESP)
    • PID: 11402085
    • Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Nephrol Dial Transplant. 2001;16(Suppl 3):3–13.
    • (2001) Nephrol Dial Transplant. , vol.16 , pp. 3-13
    • Egrie, J.C.1    Browne, J.K.2
  • 122
    • 84982794311 scopus 로고    scopus 로고
    • Chemical synthesis of erythropoietin glycoforms for insights into the relationship between glycosylation pattern and bioactivity
    • PID: 26824070
    • Murakami M, Kiuchi T, Nishihara M, Tezuka K, Okamoto R, Izumi M, et al. Chemical synthesis of erythropoietin glycoforms for insights into the relationship between glycosylation pattern and bioactivity. Sci Adv. 2016;2(1):e1500678.
    • (2016) Sci Adv. , vol.2 , Issue.1
    • Murakami, M.1    Kiuchi, T.2    Nishihara, M.3    Tezuka, K.4    Okamoto, R.5    Izumi, M.6
  • 123
    • 40849142102 scopus 로고    scopus 로고
    • Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose
    • COI: 1:CAS:528:DC%2BD1cXjt1aitLk%3D, PID: 18337601
    • Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008;358(11):1109–17.
    • (2008) N Engl J Med. , vol.358 , Issue.11 , pp. 1109-1117
    • Chung, C.H.1    Mirakhur, B.2    Chan, E.3    Le, Q.T.4    Berlin, J.5    Morse, M.6
  • 125
    • 84877309923 scopus 로고    scopus 로고
    • Biological insights into therapeutic protein modifications throughout trafficking and their biopharmaceutical applications
    • Zhong X, Wright JF. Biological insights into therapeutic protein modifications throughout trafficking and their biopharmaceutical applications. Int J Cell Biol. 2013;273086(10):273086.
    • (2013) Int J Cell Biol. , Issue.10 , pp. 273086
    • Zhong, X.1    Wright, J.F.2
  • 126
    • 84872060066 scopus 로고    scopus 로고
    • Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective
    • COI: 1:CAS:528:DC%2BC3sXislSnu70%3D, PID: 23178294
    • Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis. 2013;72(2):165–78.
    • (2013) Ann Rheum Dis. , vol.72 , Issue.2 , pp. 165-178
    • Vincent, F.B.1    Morand, E.F.2    Murphy, K.3    Mackay, F.4    Mariette, X.5    Marcelli, C.6
  • 127
    • 84883880492 scopus 로고    scopus 로고
    • Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry
    • PID: 23924791
    • Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs. 2013;5(5):621–3.
    • (2013) MAbs. , vol.5 , Issue.5 , pp. 621-623
    • Beck, A.1    Reichert, J.M.2
  • 128
    • 85008931504 scopus 로고    scopus 로고
    • Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira(R)
    • COI: 1:CAS:528:DC%2BC2sXmslKnug%3D%3D, PID: 27854156
    • Magnenat L, Palmese A, Fremaux C, D’Amici F, Terlizzese M, Rossi M, et al. Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira(R). MAbs. 2017;9(1):127–39.
    • (2017) MAbs. , vol.9 , Issue.1 , pp. 127-139
    • Magnenat, L.1    Palmese, A.2    Fremaux, C.3    D’Amici, F.4    Terlizzese, M.5    Rossi, M.6
  • 129
    • 70349769842 scopus 로고    scopus 로고
    • Human immunoglobulin allotypes: possible implications for immunogenicity
    • PID: 20073133
    • Jefferis R, Lefranc MP. Human immunoglobulin allotypes: possible implications for immunogenicity. MAbs. 2009;1(4):332–8.
    • (2009) MAbs. , vol.1 , Issue.4 , pp. 332-338
    • Jefferis, R.1    Lefranc, M.P.2
  • 130
    • 35748959960 scopus 로고    scopus 로고
    • Pure red-cell aplasia “epidemic”—mystery completely revealed?
    • PID: 17556324
    • Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia “epidemic”—mystery completely revealed? Perit Dial Int. 2007;27(2):S303–7.
    • (2007) Perit Dial Int. , vol.27 , Issue.2 , pp. S303-S307
    • Locatelli, F.1    Del Vecchio, L.2    Pozzoni, P.3
  • 132
    • 84946090981 scopus 로고    scopus 로고
    • Pharmacovigilance considerations for biosimilars in the USA
    • COI: 1:CAS:528:DC%2BC2MXhs1alu7%2FM, PID: 26419971
    • Grampp G, Felix T. Pharmacovigilance considerations for biosimilars in the USA. BioDrugs. 2015;29(5):309–21.
    • (2015) BioDrugs. , vol.29 , Issue.5 , pp. 309-321
    • Grampp, G.1    Felix, T.2
  • 133
    • 84881122457 scopus 로고    scopus 로고
    • Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases
    • PID: 23771794
    • Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Domergue F, Egberts TC, Leufkens HG, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013;36(8):617–25.
    • (2013) Drug Saf. , vol.36 , Issue.8 , pp. 617-625
    • Vermeer, N.S.1    Straus, S.M.2    Mantel-Teeuwisse, A.K.3    Domergue, F.4    Egberts, T.C.5    Leufkens, H.G.6
  • 134
    • 85010638332 scopus 로고    scopus 로고
    • To the editor; a commentary on “Switching from originator to biosimilar human growth hormone using a dialogue teamwork: single-center experience from Sweden
    • PID: 24756934
    • Ekelund M, Bidad C, Gomez R. To the editor; a commentary on “Switching from originator to biosimilar human growth hormone using a dialogue teamwork: single-center experience from Sweden”. Biol Ther. 2014;4(1–2):69–71.
    • (2014) Biol Ther. , vol.4 , Issue.1-2 , pp. 69-71
    • Ekelund, M.1    Bidad, C.2    Gomez, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.