A wide angle view of biosimilars from a bioanalytical perspective

Bioanalysis

Volumn 5, Issue 5, 2013, Pages 533-535

  Oldfield, Philip ^a  

^a Philip Oldfield Bioanalytical Consulting   (Canada)

Author keywords

biosimilar; immunoassay; immunogenicity; immunoreactivity; innovator

Indexed keywords

BIOLOGICAL MARKER; BIOSIMILAR AGENT; CD20 ANTIBODY; INSULIN; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN; NEUTRAL INSULIN; RECOMBINANT HUMAN INSULIN;

BIOLOGICAL THERAPY; CLINICAL RESEARCH; DIABETES MELLITUS; DRUG DETERMINATION; DRUG EFFICACY; DRUG LEGISLATION; DRUG POTENCY; DRUG SAFETY; GLYCOSYLATION; GOVERNMENT; HEALTH CARE QUALITY; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOREACTIVITY; INSULIN RESISTANCE; LIQUID CHROMATOGRAPHY; NONHUMAN; NOTE; PROTEIN PROCESSING; STRUCTURE ANALYSIS; TANDEM MASS SPECTROMETRY;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG EVALUATION, PRECLINICAL; GOVERNMENT REGULATION; HUMANS; IMMUNOASSAY; IMMUNOGENETIC PHENOMENA; MODELS, ANIMAL; RECOMBINANT PROTEINS;

EID: 84874161498     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.316     Document Type: Note

References (11)

1. Yallow R, Berson S. Immunoassay of endogenous plasma insulin in man. J. Clin. Investig. 39(7), 1157-1175 (1960).
2. Owen WE, Roberts WL. Cross-reactivity of three recombinant insulin analogs with five commercial insulin immunoassays. Clin. Chem. 50(1), 257-259 (2004). (Pubitemid 38125742)
3. Glenn C, Armston A. Cross-reactivity of 12 recombinant insulin preparations in the Beckman Unicel Dxl 800 insulin assay. Ann. Clin. Biochem. 47(Pt 3), 264-266 (2010).
4. Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins. Br. J. Diabetes Vasc. Dis. 10(2), 90-97 (2010).
5. Oldfield PR. Differences in bioanalytical method validation for biologically derived macromolecules (biosimilars) compared with small molecules (generics). Bioanalysis 3(14), 1551-1553 (2011).
6. Sola RJ, Griebenow K. Glycosylation of therapeutic proteins: An effective strategy to optimize efficacy. BioDrugs 24(1), 9-21 (2010).
7. Oortwijn BD, Roos A, Royle L et al. Differential glycosylation of polymeric and monoeric IgA: A possible role in glomerular inflammation in IgA nephropathy. J. Am. Soc. Nephrol. 17(12), 3529-3539, (2006). (Pubitemid 44865296)
8. Heinemann L, Hompesch M. Biosimilar insulin's: how similar is similar? J. Diabetes Sci. Technol. 5(3), 741-754 (2011).
9. European Medicines Agency. Question and Answers on Withdrawal of the Marketing Authorisation Application for Insulin Human Rapid Marvel, Insulin Human Long Marvel, Insulin Human 30/70 Mix Marvel. European Medicines Agency, London, UK (2008).
10. Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol. Dial. Transplant. 21(Suppl. 5), 4-8 (2006).
11. Lee JW, Wang Y-M, Moxness M, DeSilva B. Perspective bioanalytical considerations in the comparability assessment of biotherapeutics. Bioanalysis 3(6), 613-622 (2011).