The challenges of immunogenicity in developing biosimilar products

IDrugs

Volumn 12, Issue 7, 2009, Pages 440-444

  Wadhwa, Meenu ^a   Thorpe, Robin ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Binding antibody; Biological; Biosimilar; Follow on biological; Immunogenicity; Neutralizing antibody; Safety monitoring; Subsequent entry biological

Indexed keywords

ABSEAMED; BINOCRIT; BIOGRASTIM; ERYPRO; FILGRASTIM HEXAL; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; IMMUNOMODULATING AGENT; INSULIN; INTERFERON BETA SERINE; PEGYLATED RECOMBINANT HUMAN MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR; RATIOGRASTIM; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RETACRIT; SILAPO; TEVAGRASTIM; UNCLASSIFIED DRUG; ZARZLO;

BIOLOGICAL THERAPY; BIOTECHNOLOGY; CROSS REACTION; DRUG APPROVAL; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; NONHUMAN; REVIEW; RISK BENEFIT ANALYSIS; UNITED STATES; UNSPECIFIED SIDE EFFECT;

ANIMALS; ANTIBODIES; ANTIBODY FORMATION; DRUG APPROVAL; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; IMMUNOASSAY; PHARMACEUTICAL PREPARATIONS; RECOMBINANT PROTEINS;

EID: 68149141340     PISSN: 13697056     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. Schellekens H: How similar do 'biosimilars' need to be? Nat Biotechnol (2004) 22(11):1357-1359.
2. Schneider CK, Kalinke U: Toward biosimilar monoclonal antibodies. Nat Biotechnol (2008) 26(9):985-990.
3. Mellstedt H, Niederwieser D, Ludwig H: The challenge of biosimilars. Ann Oncol (2008) 19(3):411-419.
4. Guideline on similar biological medicinal products: European Medicines Agency, Canary Wharf, London, UK (2005). www.emea.europa.eu/pdfs/human/ biosimilar/043704en.pdf
5. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/ human/biosimilr/4934805en.pdf
6. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf
7. Guidance on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf
8. Guidance on similar medicinal products containing recombinant erythropoietins: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/human/biosimilar/1432706en.pdf
9. Guidance on similar medicinal products containing somatropin: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/ human/biosimilar/9452805 en.pdf
10. Guidance on similar medicinal products containing recombinant human insulin: European Medicines Agency, Canary Wharf, London, UK (2006). www.emea.europa.eu/pdfs/humanbiosimilar/3277505en.pdf
11. Guideline on immunogenicity assessment of biotechnology- derived therapeutic proteins: European Medicines Agency, Canary Wharf, London, UK (2007). www.emea.europa.eu/pdfs/human/biosimilar/1432706en.pdf
12. Guidance on non-clinical and clinical development of similar medicinal products containing low-molecular-weight-heparins: European Medicines Agency, Canary Wharf, London, UK (2009). www.emea.europa.eu/pdfs/human/biosimilar/ 11826407en.pdf
13. Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use has been released for consultation: European Medicines Agency, Canary Wharf, London, UK (2009). www.emea.europa. eu/pdfs/human/biosimilar/11472009en.pdf