| 1 |
AbbVie, Inc. 2021. HUMIRA® (adalimumab) injection, for subcutaneous use. [2021 Feb 02 Accessed]. Available from: https://www.rxabbvie.com/pdf/humira.pdf. |
미소장 |
| 2 |
Arora T, Padaki R, Liu L, Hamburger AE, Ellison AR, Stevens SR, Louie JS, Kohno T. 2009. Differences in binding and effector functions between classes of TNF antagonists. Cytokine. 45(2):124–131. |
미소장 |
| 3 |
Bae S, Kim MK, Kim HS, Moon YA. 2020. Arachidonic acid induces ER stress and apoptosis in HT-29 human colon cancer cells. Anim Cells Syst (Seoul). 24(5):260–266. |
미소장 |
| 4 |
Bournazos S, Ravetch JV. 2017. Diversification of IgG effector functions. Int Immunol. 29(7):303–310. |
미소장 |
| 5 |
Bruhns P, Iannascoli B, England P, Mancardi DA, Fernandez N, Jorieux S, Daëron M. 2009. Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses. Blood. 113(16):3716–3725. |
미소장 |
| 6 |
CMC Biotech Working Group (BWG). 2019. A-Mab: A case study in bioprocess development. [2021 Jan 22 Accessed]. Available from: https://cdn.ymaws.com/www.casss.org/resource/resmgr/imported/A-Mab_Case_Study_Version_2-1.pdf . |
미소장 |
| 7 |
Derbyshire M. 2019. Patent expiry dates for biologicals: 2018update. Generics and Biosimilars Initiative Journal (GaBI Journal). 8(1):24–31. |
미소장 |
| 8 |
European Medicines Agency (EMA). 2017. Biosimilars in the EU:Information guide for healthcare professionals. [2021 Feb 02Accessed]. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guidehealthcare-professionals_en.pdf. |
미소장 |
| 9 |
European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). 2014a. Guideline on similar biological medicinal product (CHMP/437/04 Rev. 1.)[2021 Feb 02 Accessed]. Available from: https://www.ema. europa.eu/en/documents/scientific-guideline/guidelinesimilar-biological-medicinal-products-rev1_en.pdf. |
미소장 |
| 10 |
European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). 2014b. Guideline on similar biologic medicinal products containing biotechnology-derived protein as active substance: quality issue (revision 1). EMA/CHMP/BWP/247713/2012. [2021 Feb 02Accessed]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biologicalmedicinal-products-containing-biotechnology-derivedproteins-active_en-0.pdf. |
미소장 |
| 11 |
Generics and Biosimilars Initiative (GaBI). 2021. Biosimilars of adalimumab. [2021 Apr 02 Accessed]. Available from:https://www.gabionline.net/Biosimilars/General/Biosimilarsof-adalimumab. |
미소장 |
| 12 |
Goetze AM, Liu YD, Zhang Z, Shah B, Lee E, Bondarenko PV, Flynn GC. 2011. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology. 21(7):949–959. |
미소장 |
| 13 |
Hayes JM, Wormald MR, Rudd PM, Davey GP. 2016. Fc gamma receptors: glycobiology and therapeutic prospects. J Inflamm Res. 9:209–219. |
미소장 |
| 14 |
Horiuchi T, Mitoma H, Harashima S, Tsukamoto H, Shimoda T. 2010. Transmembrane TNF-alpha: structure, function and interaction with anti-TNF agents. Rheumatology. 49(7):1215–1228. |
미소장 |
| 15 |
Iida S, Kuni-Kamochi R, Mori K, Misaka H, Inoue M, Okazaki A, Shitara K, Satoh M. 2009. Two mechanisms of the enhanced antibody-dependent cellular cytotoxicity (ADCC) efficacy of non-fucosylated therapeutic antibodies in human blood. BMC Cancer. 9:58. |
미소장 |
| 16 |
Iida S, Misaka H, Inoue M, Shibata M, Nakano R, Yamane-Ohnuki N, Wakitani M, Yano K, Shitara K, Satoh M. 2006. Nonfucosylated therapeutic IgG1 antibody can evade the inhibitory effect of serum immunoglobulin G on antibodydependent cellular cytotoxicity through its high binding to FcγRIIIa. Clin Cancer Res. 12(9):2879–2887. |
미소장 |
| 17 |
Jefferis R. 2009. Glycosylation as a strategy to improve antibodybased therapeutics. Nat Rev Drug Discov. 8(3):226–234. |
미소장 |
| 18 |
Jefferis R, Lund J, Pound JD. 1998. IgG-Fc-mediated effector functions: molecular definition of interaction sites for effector ligands and the role of glycosylation. Immunol Rev. 163:59–76. |
미소장 |
| 19 |
Kim MJ, Kim CH, An MJ, Lee JH, Shin GS, Song M, Kim JW. 2020. Ethylparaben induces apoptotic cell death in human placenta BeWo cells via the Caspase-3 pathway. Anim Cells Syst (Seoul). 24(1):34–43. |
미소장 |
| 20 |
Kirchhoff CF, Wang XZM, Conlon HD, Scott Anderson AM, Ryan Bose A. 2017. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 114(12):2696–2705. |
미소장 |
| 21 |
Lee C, Jeong M, Lee JJ, Seo S, Cho SC, Zhang W, Jaquez O. 2017. Glycosylation profile and biological activity of Remicade®compared with Flixabi® and Remsima®. mAbs. 9(6):968–977. |
미소장 |
| 22 |
Lee N, Lee JJ, Yang H, Baek S, Kim S, Kim S, Lee T, Song D, Park G. 2019. Evaluation of similar quality attribute characteristics in SB5 and reference product of Adalimumab. mAbs. 11(1):129–144. |
미소장 |
| 23 |
Li CH, Nguyen X, Narhi L, Chemmalil L, Towers E, Muzammil S, Gabrielson J, Jiang Y. 2011. Applications of circular dichroism (CD) for structural analysis of proteins: qualification of near- and far-UV CD for protein higher order structural analysis. J Pharm Sci. 100(11):4642–4654. |
미소장 |
| 24 |
Liu H, May K. 2012. Disulfide bond structures of IgG molecules:structural variations, chemical modifications and possible impacts to stability and biological function. mAbs. 4(1):17–23. |
미소장 |
| 25 |
McCamish M, Woollett G. 2011. Worldwide experience with biosimilar development. mAbs. 3(2):209–217. |
미소장 |
| 26 |
Mitoma H, Horiuchi T, Tsukamoto H, Tamimoto Y, Kimoto Y, Uchino A, To K, Harashima S, Hatta N, Harada M. 2008. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 58(5):1248–1257. |
미소장 |
| 27 |
Nimmerjahn F, Ravetch JV. 2008. Fcgamma receptors as regulators of immune responses. Nat Rev Immunol. 8(1):34–47. |
미소장 |
| 28 |
Olesen CM, Coskun M, Peyrin-Biroulet L, Nielsen OH. 2016. Mechanisms behind efficacy of tumor necrosis factor inhibitors in inflammatory bowel diseases. Pharmacol Ther. 159:110–119. |
미소장 |
| 29 |
Reusch D, Tejada ML. 2015. Fc glycans of therapeutic antibodies as critical quality attributes. Glycobiology. 25(12):1325–1334. |
미소장 |
| 30 |
Rosales C, Uribe-Querol E. 2013. Fc receptors: cell activators of antibody functions. Adv Biosci Biotechnol. 4:21–33. |
미소장 |
| 31 |
Satoh M, Iida S, Shitara K. 2006. Non-fucosylated therapeutic antibodies as next-generation therapeutic antibodies. Expert Opin Biol Ther. 6(11):1161–1173. |
미소장 |
| 32 |
Shields RL, Lai J, Keck R, O’Connell LY, Hong K, Meng YG, Weikert SH, Presta LG. 2002. Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity. J Biol Chem. 277(30):26733–26740. |
미소장 |
| 33 |
Thiagarajan G, Semple A, James JK, Cheung JK, Shameem M. 2016. A comparison of biophysical characterization techniques in predicting monoclonal antibody stability. mAbs. 8(6):1088–1097. |
미소장 |
| 34 |
Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. 2008. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 117(2):244–279. |
미소장 |
| 35 |
Tsong Y, Dong X, Shen M. 2017. Development of statistical methods for analytical similarity assessment. J Biopharm Stat. 27(2):197–205. |
미소장 |
| 36 |
Ueda N, Tsukamoto H, Mitoma H, Ayano M, Tanaka A, Ohta S, Inoue Y, Arinobu Y, Niiro H, Akashi K, Horiuchi T. 2013. The cytotoxic effects of certolizumab pegol and golimumab mediated by transmembrane tumor necrosis factor α. Inflamm Bowel Dis. 19:1224–1231. |
미소장 |
| 37 |
U.S. Food and Drug Administration (FDA). 2015a. Guidance for Industry: scientific considerations in demonstrating biosimilarity to a reference product. [2021 Feb 02 Accessed]. Available from: https://www.fda.gov/media/82647/download. |
미소장 |
| 38 |
U.S. Food and Drug Administration (FDA). 2015b. Guidance for Industry: Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. [2021 Feb 02 Accessed]. Available from: https://www.regulations.gov/document?D=FDA-2011-D-0602-0051. |
미소장 |
| 39 |
U.S. Food and Drug Administration (FDA). 2017. Biological product definitions. [2021 Feb 02 Accessed]. Available from: https://www.fda.gov/media/108557/download. |
미소장 |
| 40 |
U.S. Food and Drug Administration (FDA). 2019. Guidance for Industry: development of therapeutic protein biosimilars:comparative analytical assessment and other qualityrelated considerations. [2021 Apr 02 Accessed]. Available from: https://www.fda.gov/media/125484/download. |
미소장 |
| 41 |
Ward ES, Devanaboyina SC, Ober RJ. 2015. Targeting FcRn for the modulation of antibody dynamics. Mol Immunol. 67(2Pt A):131–141. |
미소장 |
| 42 |
Zhang E, Xie L, Qin P, Lu L, Xu Y, Gao W, Wang L, Xie MH, Jiang W, Liu S. 2020. Quality by design-based assessment for analytical similarity of adalimumab biosimilar HLX03 to Humira®. AAPS J. 22(3):69. |
미소장 |
| 43 |
Zheng K, Bantog C, Bayer R. 2011. The impact of glycosylation on monoclonal antibody conformation and stability. MAbs. 3(6):568–576. |
미소장 |