Immunogenicity and its impact on benefit/risk considerations in the authorisation of biopharmaceuticals

Current Drug Safety

Volumn 5, Issue 4, 2010, Pages 287-292

  Büttel, Isabel C ^a   Völler, Katrin ^a   Schneider, Christian K ^a,b  

^a PAUL EHRLICH INSTITUT   (Germany)

^b INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

Author keywords

Benefit risk; Biotechnology derived proteins; Immunogenicity; Regulatory guideline; Risk assessment

Indexed keywords

ANTIBODY; ANTIDRUG ANTIBODY; BETA INTERFERON; DACLIZUMAB; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; OKT 3; UNCLASSIFIED DRUG; VACCINE;

ANTIBODY PRODUCTION; ARTICLE; DRUG APPROVAL; DRUG EFFECT; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG STORAGE; GENE DELETION; GLYCOSYLATION; GOVERNMENT REGULATION; HEREDITY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INTERMETHOD COMPARISON; MEDICINAL PLANT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSORIASIS; PURE RED CELL ANEMIA; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; THROMBOCYTOPENIA; TREATMENT INDICATION;

ANTIBODY FORMATION; BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; LEGISLATION, DRUG; MARKETING; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT;

EID: 77958462869     PISSN: 15748863     EISSN: None     Source Type: Journal    
DOI: 10.2174/157488610792245993     Document Type: Article

References (32)

1. Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephro Dial Transplant 2005; 20(Suppl 6): 3-9.
2. Chackerian B, Lenz P, Lowy DR, Schiller JT. Determinants of autoantibody induction by conjugated papillomavirus virus-like particles. J Immunol 2002; 169: 6120-6126.
3. Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol 2007; 25: 555-561.
4. Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002; 346: 469-475.
5. European Medicines Agency (EMA): Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins EMA/CHMP/ BMWP/14327/2006 (2007). http://www.EMA.europa.eu/pdfs/human/biosimilar/1432706enfin.pdf
6. McIntyre JA, Kincade M, Higgins NG. Detection of IGA anti- OKT3 antibodies in OKT3-treated transplant recipients. Transplantation 1996; 61:1465-1469.
7. Matzinger P. The danger model: a renewed sense of self. Science 2002; 296: 301-5.
8. Goochee CF, Monica T. Environmental effects on protein glycosylation. Biotechnology (N.Y.) 1990; 8: 421-427.
9. Gribben JG, Devereux S, Thomas NS, et al. Development of antibodies to unprotected glycosylation sites on recombinant human GM-CSF. Lancet 1990; 335: 434-437
10. Ross C, Clemmesen KM, Svenson M, et al. Immunogenicity of interferon-beta in multiple sclerosis patients: influence of preparation, dosage, dose frequency, and route of administration. Danish Multiple Sclerosis Study Group. Ann Neurol 2000; 48: 706-712.
11. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 2006; 21(Suppl 5): v9-v12.
12. Bhadra D, Bhadra S, Jain P, Jain NK. Pegnology: a review of PEGylated systems. Pharmazie 2002; 57: 5-29.
13. Davis FF. The origin of pegnology. Adv Drug Deliv Rev 2002; 54: 457-458.
14. Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 2002; 24: 1720-1740.
15. Remicade, European Public Assessment Report, European Medicines Agency. http://www.EMA.europa.eu/humandocs/PDFs/EPAR/Remicade/190199en6.pdf
16. Jahn EM and Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins: Regulatory considerations. N Biotechnol 2009; 25(5): 280-286.
17. European Medicines Agency (EMA): Zenapax, European Public Assessment Report. http://www.EMA.europa.eu/humandocs/Humans/EPAR/zenapax/zenapax.htm.
18. Li J, Yang C, Xia Y, et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 2001; 98: 3241-3248.
19. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008, 300:1887-1896.
20. Mire-Sluis AR, Barrett YC, Devanarayan V, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004; 289: 1-16.
21. Wadhwa M, Thorpe R. Strategies and assays for the assessment of unwanted immunogenicity. J Immunotoxicol 2006; 3: 115-121.
22. Gupta S, Indelicato SR, Jethwa V, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods 2007; 321: 1-18.
23. DeSilva B, Smith W, Weiner R, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 2003; 20: 1885-1900.
24. Kelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules. AAPS J 2007; 9: 156-163.
25. European Medicines Agency (EMA): BMWP/BWP Workshop on Immunogenicity Assessment of Therapeutic Proteins (2007).http://www.EMA.europa.eu/meetings/conferences/4sep07.htm
26. Schneider CK, Papaluca M, Kurki P. A European perspective on immunogenicity evaluation. Nat Biotechnol 2009, 27(6): 507-508.
27. European Medicines Agency (EMA): Summary of Product Characteristics (SmPC) of Tysabri. http://www.EMA.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-PI-en.pdf.
28. Taylor N. Myozyme-becomes-Lumizyme-after-biologics-scale-up.In-pharma technologist 2009. http://www.in-pharmatechnologist.com/Materials-Formulation/Myozyme-becomes-Lumizyme-afterbiologics-scale-up
29. Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies. Nat Biotechnol. 2008; 26: 985-990.
30. Schneider CK, Schaffner-Dallmann G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 2008; 7: 893-899.
31. European Medicines Agency (EMA): Concept Paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMA/CHMP/BMWP/114720/2009 (2009). http://www.EMA.europa.eu/pdfs/human/biosimilar/11472009en.pdf
32. Reichert JM, Rosensweig CJ, Faden LB, Dewitz MC. Monoclonal antibody successes in the clinic. Nat Biotechnol 2005; 23: 1073-1078.