Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products

mAbs

Volumn 4, Issue 6, 2012, Pages 761-774

  Tan, Qingqiao ^a,b   Guo, Qingcheng ^a,b   Fang, Chen ^a   Wang, Chong ^a,b   Li, Bohua ^a,b,c   Wang, Hao ^a,b,c   Li, Jing ^a,b   Guo, Yajun ^a,b,c  

^a SECOND MILITARY MEDICAL UNIVERSITY   (China)

^b National Engineering Research Center of Antibody Medicine   (China)

^c CHINESE PLA GENERAL HOSPITAL   (China)

Author keywords

Biosimilar; CE LIF; Charge variant; Etanercept; Intact mass; MS MS; N Glycosylation; Sialic acid; TNF receptor 2 fc fusion protein

Indexed keywords

AMINO ACID; ETANERCEPT; HYBRID PROTEIN; OLIGOSACCHARIDE; TUMOR NECROSIS FACTOR RECEPTOR 2;

AMINO ACID SEQUENCE; ARTICLE; CLINICAL ARTICLE; DRUG ACTIVITY; DRUG HALF LIFE; GLYCOSYLATION; HEAVY CHAIN; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; PEPTIDE MAPPING; PHYSICAL CHEMISTRY; POLYACRYLAMIDE GEL ELECTROPHORESIS; TANDEM MASS SPECTROMETRY;

BIOSIMILAR; CE-LIF; CHARGE VARIANT; ETANERCEPT; INTACT MASS; MS/MS; N-GLYCOSYLATION; SIALIC ACID; TNF RECEPTOR 2-FC FUSION PROTEIN;

ANIMALS; ANTIBODY AFFINITY; BIOSIMILAR PHARMACEUTICALS; CELL LINE; EUROPE; FIBROBLASTS; GLYCOSYLATION; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOGLOBULIN G; MICE; RECEPTORS, TUMOR NECROSIS FACTOR; RECEPTORS, TUMOR NECROSIS FACTOR, TYPE II; RECOMBINANT FUSION PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 84869757230     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.22276     Document Type: Article

References (48)

1. Jenkins N, Parekh RB, James DC. Getting the glycosylation right: implications for the biotechnology industry. Nat Biotechnol 1996; 14:975-81; PMID:9631034; http://dx.doi.org/10.1038/nbt0896-975
2. Reichert JM, Rosensweig CJ, Faden LB, Dewitz MC. Monoclonal antibody successes in the clinic. Nat Biotechnol 2005; 23:1073-8; PMID:16151394; http://dx.doi.org/10.1038/nbt0905-1073
3. Beck A, Wagner-Rousset E, Bussat MC, Lokteff M, Klinguer-Hamour C, Haeuw JF, et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr Pharm Biotechnol 2008; 9:482-501; PMID:19075687; http://dx.doi.org/10.2174/138920108786786411
4. Reichert JM. Antibodies to watch in 2010. MAbs 2010; 2:84-100; PMID:20065640; http://dx.doi.org/10.4161/mabs.2.1.10677
5. Oldham RK, Dillman RO. Monoclonal antibodies in cancer therapy: 25 years of progress. J Clin Oncol 2008; 26:1774-7; PMID:18398141; http://dx.doi.org/10. 1200/JCO.2007.15.7438
6. European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04. 2005. www. ema.europa.eu/pdfs/human/biosimilar/043704en. pdf
7. European Medicines Agency. Guideline on similarbiological medicinal products containing biotechnology-derived proteins as active substance: quality issues. EMEA/CHMP/BWP/49348/2005. 2006. http://www.emea.europa.eu/docs/en-GB/ document-library/ Scientific-guideline/2009/09/WC500003953.pdf
8. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005. 2006. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/ WC500003920.pdf
9. Gottlieb S. Biosimilars: policy, clinical, and regulatory considerations. Am J Health Syst Pharm 2008; 65(Suppl 6):S2-8; PMID:18591712; http://dx.doi.org/10.2146/ajhp080210
10. Ahmed I, Kaspar B, Sharma U. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012; 34:400-19; PMID:22244050; http://dx.doi.org/10.1016/j. clinthera.2011.12.005
11. Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29:310-2; PMID:21478841; http://dx.doi.org/10.1038/nbt.1839
12. Stanhope R, Sörgel F, Gravel P, Pannatier Schuetz YB, Zabransky M, Muenzberg M. Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. J Clin Pharmacol 2010; 50:1339-48; PMID:20173088; http://dx.doi.org/10.1177/0091270009359005
13. Romer T, Saenger P, Peter F, Walczak M, Le Bouc Y, Khan-Boluki J, et al. Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study. Horm Res 2009; 72:359-69; PMID:19844125; http://dx.doi.org/10. 1159/000249164
14. Pavlovic M, Girardin E, Kapetanovic L, Ho K, Trouvin JH. Similar biological medicinal products containing recombinant human growth hormone: European regulation. Horm Res 2008; 69:14-21; PMID:18059081; http://dx.doi.org/10.1159/000111790
15. Romer T, Peter F, Saenger P, Starzyk J, Koehler B, Korman E, et al. Efficacy and safety of a new ready-to-use recombinant human growth hormone solution. J Endocrinol Invest 2007; 30:578-89; PMID:17848841
16. Peterkova V, Arslanoglu I, Bolshova-Zubkovskaya E, Romer T, Zdravkovic D, Kratzsch J, et al. A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. Horm Res 2007; 68:288-93; PMID:17627092; http://dx.doi.org/10.1159/000105494
17. Skrlin A, Radic I, Vuletic M, Schwinke D, Runac D, Kusalic T, et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 2010; 38:557-66; PMID:20637652; http://dx.doi.org/10.1016/j.biologicals.2010.05.002
18. Waller CF, Bronchud M, Mair S, Challand R. Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010; 89:927-33; PMID:20428872; http://dx.doi.org/10.1007/ s00277-010-0961-x
19. Waller CF, Bronchud M, Mair S, Challand R. Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010; 89:971-8; PMID:20567823; http://dx.doi.org/10.1007/ s00277-010-0973-6
20. Waller CF, Semiglazov VF, Tjulandin S, Bentsion D, Chan S, Challand R. A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Onkologie 2010; 33:504-11; PMID:20926897; http://dx.doi.org/10.1159/ 000319693
21. Sörgel F, Lerch H, Lauber T. Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product. BioDrugs 2010; 24:347-57; PMID:20873878; http://dx.doi.org/ 10.2165/11585100-000000000-00000
22. Gascon P, Fuhr U, Sörgel F, Kinzig-Schippers M, Makhson A, Balser S, et al. Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol 2010; 21:1419-29; PMID:20019087; http://dx.doi.org/10.1093/annonc/ mdp574
23. Lubenau H, Sveikata A, Gumbrevicius G, Macijauskiene J, Fokas V, Kazlauskas S, et al. Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharmacol Ther 2009; 47:275-82; PMID:19356394
24. Lubenau H, Bias P, Maly AK, Siegler KE, Mehltretter K. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs 2009; 23:43-51; PMID:19344191; http://dx.doi.org/10.2165/00063030- 200923010-00005
25. Haag-Weber M, Vetter A, Thyroff-Friesinger U; INJStudy Group. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 2009; 72:380-90; PMID:19863881
26. Krivoshiev S, Todorov VV, Manitius J, Czekalski S, Scigalla P, Koytchev R; Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin 2008; 24:1407-15; PMID:18394266; http://dx.doi.org/10.1185/030079908X297402
27. Wizemann V, Rutkowski B, Baldamus C, Scigalla P, Koytchev R; Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin 2008; 24:625-37; PMID:18208642; http://dx.doi.org/10.1185/030079908X273264
28. Grattendick KJ, Nakashima JM, Feng L, Giri SN, Margolin SB. Effects of three anti-TNF-α drugs: etanercept, infliximab and pirfenidone on release of TNF-α in medium and TNF-α associated with the cell in vitro. Int Immunopharmacol 2008; 8:679-87; PMID:18387510; http://dx.doi.org/10.1016/j. intimp.2008.01.013
29. Peppel K, Crawford D, Beutler B. A tumor necrosis factor (TNF) receptor-IgG heavy chain chimeric protein as a bivalent antagonist of TNF activity. J Exp Med 1991; 174:1483-9; PMID:1660525; http://dx.doi.org/10.1084/ jem.174.6.1483
30. Peppel K, Poltorak A, Melhado I, Jirik F, Beutler B. Expression of a TNF inhibitor in transgenic mice. J Immunol 1993; 151:5699-703; PMID:7693816
31. Kolls J, Peppel K, Silva M, Beutler B. Prolonged and effective blockade of tumor necrosis factor activity through adenovirus-mediated gene transfer. Proc Natl Acad Sci U S A 1994; 91:215-9; PMID:8278368; http://dx.doi.org/10. 1073/pnas.91.1.215
32. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008; 117:244-79; PMID:18155297; http://dx.doi.org/10.1016/j.pharmthera.2007.10. 001
33. http://www.drugbank.ca/drugs/DB00005
34. RECOMMENDED INN. List 43. WHO Drug Information 2000; 14:51
35. U.S. Patent number: 5605690
36. Raju TS. Terminal sugars of Fc glycans influence antibody effector functions of IgGs. Curr Opin Immunol 2008; 20:471-8; PMID:18606225; http://dx.doi.org/10.1016/j.coi.2008.06.007
37. Nimmerjahn F, Ravetch JV. The antiinflammatory activity of IgG: the intravenous IgG paradox. J Exp Med 2007; 204:11-5; PMID:17227911; http://dx.doi.org/10.1084/jem.20061788
38. Magdelaine-Beuzelin C, Kaas Q, Wehbi V, Ohresser M, Jefferis R, Lefranc MP, et al. Structure-function relationships of the variable domains of monoclonal antibodies approved for cancer treatment. Crit Rev Oncol Hematol 2007; 64:210-25; PMID:17624800; http://dx.doi.org/10.1016/j.critrevonc.2007.04. 011
39. Walsh G, Jefferis R. Post-translational modifications in the context of therapeutic proteins. Nat Biotechnol 2006; 24:1241-52; PMID:17033665; http://dx.doi.org/10.1038/nbt1252
40. Hancock WS. Glycosylation, who cares? J Proteome Res 2002; 1:297; PMID:12645884; http://dx.doi. org/10.1021/pr0203363
41. Jefferis R. Glycosylation of recombinant antibody therapeutics. Biotechnol Prog 2005; 21:11-6; PMID:15903235; http://dx.doi.org/10.1021/ bp040016j
42. Grattendick KJ, Nakashima JM, Feng L, Giri SN, Margolin SB. Effects of three anti-TNF-alpha drugs: etanercept, infliximab and pirfenidone on release of TNF-alpha in medium and TNF-alpha associated with the cell in vitro. Int Immunopharmacol 2008; 8:679-87; PMID:18387510; http://dx.doi.org/10.1016/j. intimp.2008.01.013
43. Scallon B, Cai A, Solowski N, Rosenberg A, Song XY, Shealy D, et al. Binding and functional comparisons of two types of tumor necrosis factor antagonists. J Pharmacol Exp Ther 2002; 301:418-26; PMID:11961039; http://dx.doi.org/10.1124/ jpet.301.2.418
44. 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
45. Takeuchi M, Inoue N, Strickland TW, Kubota M, Wada M, Shimizu R, et al. Relationship between sugar chain structure and biological activity of recombinant human erythropoietin produced in Chinese hamster ovary cells. Proc Natl Acad Sci U S A 1989; 86:7819-22; PMID:2813359; http://dx.doi.org/10.1073/ pnas.86.20.7819
46. Xie H, Chakraborty A, Ahn J, Yu YQ, Dakshinamoorthy DP, Gilar M, et al. Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies. MAbs 2010; 2:379-94; PMID:20458189
47. Beck A, Sanglier-Cianférani 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
48. 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