Physicochemical characterization of Remsima®

mAbs

Volumn 6, Issue 5, 2014, Pages 1163-1177

  Jung, Soon Kwan ^a   Lee, Kyoung Hoon ^a   Jeon, Jae Won ^a   Lee, Joon Won ^a   Kwon, Byoung Oh ^a   Kim, Yeon Jung ^a   Soo, Jin Bae ^a   Kim, Dong I I ^b   Lee, Soo Young ^a   Chang, Shin Jae ^a  

^a Celltrion Inc   (South Korea)

^b Inha University   (South Korea)

Author keywords

Biosimilar; Characterization; Comparability; CT P13; Infliximab; Reference medicinal product (Rmp); Remicade ; Remsima

Indexed keywords

INFLIXIMAB; LYSINE;

AMINO ACID SEQUENCE; ARTICLE; BINDING AFFINITY; CARBOXY TERMINAL SEQUENCE; DISULFIDE BOND; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; GLYCOSYLATION; IN VITRO STUDY; IN VIVO STUDY; PHYSICAL CHEMISTRY;

EID: 84913533583     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.32221     Document Type: Article

References (26)

1. Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol 2012; 7(Suppl 1):S57-67; PMID:22249658; http://dx.doi.org/10.1007/s11523-011-0196-3
2. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotech-nology-derived proteins as active substance: nonclinical and clinical issues (revision 1). London: European Medicines Agency 2014; Available from: http:// www.ema.europa.eu/">www.ema.europa.eu/docs/en- GB/document-library/Scientific-guideline/2012/05/ WC500127960.pdf.
3. Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. Rockville: Food and Drug Administration 2012; Available from: www.fda. gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM291134.pdf">http://www. fda.gov/">www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM29 1134.pdf.
4. GaBi online. Biosimilars approved in Europe. 2011; July 8. Available from: http://gabionline.net/Biosimilars/General/ Biosimilars-approved-in-Europe.
5. Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, Hixon D, Joneckis C, Kozlowski S, Rosenberg A, et al. The FDA's assessment of followon protein products: a historical perspective. Nat Rev Drug Discov 2007; 6:437-42; PMID:17633790; http://dx.doi.org/10.1038/nrd2307
6. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Remsima - European public assessment report (EPAR). 2013; Available from: www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Public-assessment-report/ human/002576/WC500151486.pdf">http://www. ema.europa.eu/">www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Public-assessment-report/ human/002576/WC500151486.pdf.
7. Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs 2013; 5:621-3; PMID:23924791; http://dx.doi.org/10.4161/mabs.25864
8. Beck A, Dimer H, Ayoub D, Debaene F, Wagner-Rousset E, Carapito D, Van Dorsselaer A, Sanglier-Cianfërani S. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Analyt Chem 2013; 48:81-95; http://dx.doi.org/10.1016/j. trac.2013.02.014
9. Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianfërani S. Characterization of therapeutic antibodies and related products. Anal Chem 2013; 85:715-36; PMID:23134362; http://dx.doi.org/10.1021/ac3032355
10. Beck A, Sanglier-Cianfërani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 2012; 84:4637-46; PMID:22510259; http://dx.doi.org/ 10.1021/ac3002885
11. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov 2012; 11:527-40; PMID:22743980; http://dx.doi.org/ 10.1038/nrd3746
12. Xie H, Chakraborty A, Ahn J, Yu YQ, Dakshinamoorthy DP, Gilar M, Chen W, Skilton SJ, Mazzeo JR. Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies. MAbs 2010; 2:11986; PMID:20458189; http://dx.doi. org/10.4161/mabs.11986
13. Gahoual R, Burr A, Busnel JM, Kuhn L, Hammann P, Beck A, François YN, Leize-Wagner E. Rapid and multi-level characterization of trastuzumab using sheathless capillary electrophoresis-tandem mass spectrometry. MAbs 2013; 5:479-90; PMID:23563524; http://dx.doi.org/10.4161/mabs.23995
14. Visser J, Feuerstein I, Stangler T, Schmiederer T, Fritsch C, Schiestl M. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs 2013; 27:495-507; PMID:23649935; http://dx.doi. org/10.1007/s40259-013-0036-3
15. Chen SL, Wu SL, Huang LJ, Huang JB, Chen SH. A global comparability approach for biosimilar monoclonal antibodies using LC-tandem MS based proteomics. J Pharm Biomed Anal 2013; 80:126-35; PMID:23563225; http://dx.doi.org/10.1016/j.jpba.2013.02.040
16. Lubiniecki A, Volkin DB, Federici M, Bond MD, Nedved ML, Hendricks L, Mehndiratta P, Bruner M, Burman S, Dalmonte P, et al. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals 2011; 39:9-22; PMID:20888784; http:// dx.doi.org/10.1016/j.biologicals.2010.08.004
17. Wen J, Jiang Y, Nahri L. Effect of carbohydrate on thermal stability of antibodies. Am Pharm Rev 2008:1-6.
18. Wang X, Li Q, DaviesM. Development of antibody arrays for monoclonal antibody Higher Order Structure analysis. Front Pharmacol 2013; 4:103; PMID:23970865; http:// dx.doi.org/10.3389/fphar.2013.00103
19. Wang X, Li Q, Davies D. Higher order structure comparability: Case studies of biosimilar monoclonal antibodies. Bioprocess Int 2014; 12:32-7.
20. Reichert JM, Beck A, Iyer H. European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK. MAbs 2009; 1:394-416; PMID:20065643; http://dx.doi.org/10.4161/ mabs.1.5.9630
21. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Ureña S, Lim M, Lee Y-A, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72:1605-12; PMID:23687259; http://dx.doi.org/ 10.1136/annrheumdis-2012-203091
22. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA. Ann Rheum Dis 2013; 72:1613-20; PMID:23687260; http://dx.doi.org/ 10.1136/annrheumdis-2012-203090
23. Otwinowski Z, Minor W. Processing of X-ray diffraction data collected in oscillation mode. Methods Enzymol 1997; 276:307-26; http://dx.doi.org/10.1016/ S0076-6879(97)76066-X
24. Brunger AT. Version 1.2 of the Crystallography andNMR system. Nat Protoc 2007; 2:2728-33; PMID:18007608; http://dx.doi.org/10.1038/nprot.2007.406
25. Emsley P, Cowtan K. Coot: model-building tools for molecular graphics. Acta Crystallogr D Biol Crystallogr 2004; 60:2126-32; PMID:15572765; http://dx.doi. org/10.1107/S0907444904019158
26. Laskowski RA, MacArthurMW, Moss DS, Thornton JM. PROCHECK - a program to check the stereochemical quality of protein structures. J Appl Cryst 1993; 26:283-91; http://dx.doi.org/10.1107/S0021889892009944