Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013

Leukemia and Lymphoma

Volumn 55, Issue 7, 2014, Pages 1609-1617

  Da Silva, Antonio ^a   Kronthaler, Ulrich ^a   Koppenburg, Vera ^a   Fink, Martin ^b   Meyer, Ines ^a   Papandrikopoulou, Anastassia ^a   Hofmann, Matthias ^b   Stangler, Thomas ^b   Visser, Jan ^a  

^a Sandoz Biopharmaceuticals   (Germany)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Antibody dependent cellular cytotoxicity; Biosimilars; Non Hodgkin lymphoma; Rituximab

Indexed keywords

BIOSIMILAR AGENT; CD20 ANTIGEN; RITUXIMAB; ANTINEOPLASTIC AGENT; POLYSACCHARIDE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; AREA UNDER THE CURVE; ARTICLE; BIOLOGICAL ACTIVITY; CANCER CELL LINE; CONTROLLED STUDY; DRUG POTENCY; GLYCOSYLATION; IN VITRO STUDY; IN VIVO STUDY; LYMPHOMA CELL LINE; MACACA FASCICULARIS; MOUSE; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; PROTEIN PROCESSING; SINGLE DRUG DOSE; STRUCTURE ACTIVITY RELATION; ANIMAL; CHEMISTRY; DISEASE MODEL; DRUG EFFECTS; DRUG SCREENING; HUMAN; IMMUNOLOGY; MOLECULARLY TARGETED THERAPY; NEOPLASMS; PATHOLOGY; PRECLINICAL STUDY; PROTEIN ENGINEERING; TUMOR VOLUME;

ANIMALS; ANTIBODY-DEPENDENT CELL CYTOTOXICITY; ANTINEOPLASTIC AGENTS; BIOSIMILAR PHARMACEUTICALS; DISEASE MODELS, ANIMAL; DRUG EVALUATION, PRECLINICAL; GLYCOSYLATION; HUMANS; MACACA FASCICULARIS; MICE; MOLECULAR TARGETED THERAPY; NEOPLASMS; POLYSACCHARIDES; PROTEIN ENGINEERING; RITUXIMAB; TUMOR BURDEN; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84900481066     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428194.2013.843090     Document Type: Article

References (29)

1. Brekke OH, Sandlie I. Therapeutic antibodies for human diseasesat the dawn of the twenty-fi rst century. Nat Rev Drug Discov 2003 ; 2 :52-62.
2. Reichert JM. Trends in US approvals: new biopharmaceuticalsand vaccines. Trends Biotechnol 2006; 24: 293-298.
3. Cornes P. The economic pressures for biosimilar drug use in cancermedicine. Target Oncol 2012; 7(Suppl. 1): S57-S67.
4. McCamish M, Woollett G. Worldwide experience with biosimilardevelopment. MAbs 2011; 3: 209-217.
5. McCamish M, Woollett G. The state of the art in the development ofbiosimilars. Clin Pharmacol Ther 2012 ; 91 : 405-417.
6. European Medicines Agency, Committee for Medicinal Productsfor Human Use (CHMP). Guideline on similar biological medicinalproducts containing monoclonal antibodies-non-clinical andclinical issues. London: European Medicines Agency; 2012. Availablefrom: http://www.ema.europa.eu/docs/en-GB/document-library/ Scientifi c-guideline/2012/06/WC500128686.pdf
7. Food and Drug Administration, Center for Drug Evaluation andResearch (CDER). Guidance for Industry. Scientifi c considerations indemonstrating biosimilarity to a reference product. Rockville, MD, Food and Drug Administration ; 2012. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
8. Schiestl M, Stangler T, Torella C, et al. Acceptable changes inquality attributes of glycosylated biopharmaceuticals. Nat Biotechnol2011 ; 29 : 310-312.
9. Berkowitz S A, Engen J R, Mazzeo J R, et al. Analytical toolsfor characterizing biopharmaceuticals and the implications forbiosimilars. Nat Rev Drug Discov 2012 ; 11 : 527-540.
10. Beck A, Diemer H, Ayoub D, et al. Analytical characterizationof biosimilar antibodies and Fc-fusion proteins. Trends Anal Chem2013 ; 48 : 81-95.
11. Cartron G, Dacheux L, Salles G, et al. Therapeutic activity ofhumanized anti-CD20 monoclonal antibody and polymorphism in IgGFc receptor FcgammaRIIIa gene. Blood 2002 ; 99 : 754-758.
12. van Meerten T, van Rijn RS, Hol S, et al. Complement-inducedcell death by rituximab depends on CD20 expression level and actscomplementary to antibody-dependent cellular cytotoxicity. ClinCancer Res 2006; 12: 4027-4035.
13. Weiner GJ. Rituximab: mechanism of action. Semin Hematol2010 ; 47 : 115-123.
14. Maloney DG, Smith B, Rose A. Rituximab: mechanism of actionand resistance. Semin Oncol 2002; 29(Suppl. 2): 2-9.
15. Vital EM, Kay J, Emery P. Rituximab biosimilars. Expert Opin BiolTher 2013 ; 13 : 1049-1062.
16. Dorvignit D, Palacios J L, Merino M, et al. Expression and biologicalcharacterization of an anti-CD20 biosimilar candidate antibody. Acasestudy. mAbs 2012 ; 4 : 488-496.
17. Visser J, Feuerstein I, Stangler T, et al. Physicochemical and functionalcomparability between the proposed biosimilar rituximab GP 2013and originator rituximab. BioDrugs 2013; 27 : 495-507.
18. Jiang X-R, Song A, Bergelson S, et al. Advances in the assessmentand control of the eff ector functions of therapeutic antibodies. Nat RevDrug Discov 2011 ; 10 : 101-111.
19. Beck A, Sanglier-Cianferani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by massspectroscopy. Anal Chem 2012 ; 84 : 4637-4646.
20. Vugmeyster Y, Howell K, Bakshl A, et al. Eff ect of anti-CD20monoclonal antibody, Rituxan, on cynomolgus monkey and human Bcells in a whole blood matrix. Cytometry 2003 ; 52 : 101-109.
21. Tao MH, Morrison SL. Studies of aglycosylated chimeric mousehumanIgG. Role of carbohydrate in the structure and eff ectorfunctions mediated by the human IgG constant region. JImmunol1989 ; 143 : 2595-2601.
22. Kubota T, Niwa R, Satoh M, et al. Engineered therapeutic antibodieswith improved eff ector functions. Cancer Sci 2009 ; 100 :1566-1572.
23. Li C, Rossomando A, Wu S-L, et al. Comparability analysis ofanti-CD20 commercial (rituximab) and RNAi-mediated fucosylatedantibodies by two LC-MS approaches. mAbs 2013; 5: 565-575.
24. Shields RL, Lai J, Keck R, et al. Lack of fucose on human IgG1N-linked oligosaccharide improves binding to human FcgammaRIII and antibody-dependent cellular toxicity. JBiol Chem 2002 ; 277 :26733-26740.
25. de Romeuf C, Dutertre CA, Le Garff-Tavernier M, et al.Chronic lymphocytic leukaemia cells are efficiently killed byan anti-CD20 monoclonal antibody selected for improvedengagement of FcgammaRIIIA/CD16. Br J Haematol 2008 ; 140 :635-643.
26. Chung S, Quarmby V, Gao X, et al. Quantitative evaluation offucose reducing eff ects in a humanized antibody on Fc receptorbinding and antibody-dependent cell-mediated cytotoxicity activities.mAbs 2012 ; 4 : 326-340.
27. Ternant D, Paintaud G. Pharmacokinetics and concentrationeffect relationships of therapeutic monoclonal antibodies and fusionproteins. Expert Opin Biol Ther 2005; 5(Suppl. 1): S37-S47.
28. Wang W, Lu P, Fang Y, et al. Monoclonal antibodies with identicalFc sequences can bind to FcRn diff erentially with pharmacokineticconsequences. Drug Metab Dispos 2011 ; 39 : 1469-1477.
29. Keizer RJ, Huitema AD, Schellens JH, et al. Clinicalpharmacokinetics of therapeutic monoclonal antibodies. ClinPharmacokinet 2010; 49: 493-507.