Review Liu, Zou, Sadhu, Shen & Nock
Assay selection & validation There is still a debate on assay approaches for com- parative immunogenicity assessment. A large number of studies for biosimlar development are currently in the clinical stages, many biosimilar programs are going to start their clinical trials in a very near future. It is expected that accumulated experience will provide meaningful information for choosing an appropriate assay approach for the immunogenicity testing. We
Executive summary
• For the successful development of a biosimilar, its clinical immunogenicity profile needs to be comparable to that of the reference product.
• Subject and sampling factors should be considered thoroughly for the development of a comparative clinical immunogenicity study plan, since these can contribute to the observed immune response in ways independent of the therapeutics.
• Regardless of the assay strategy, demonstration of assay capability (one-assay approach) and equivalence (product-specific assay approach) for detecting anti-drug antibodies against a proposed biosimilar product versus its reference product is critical for method development and validation, so that high qaulity and scientifically sound data can be obtained for a meaningful comparative immunogenicity assessment.
References
1 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products.
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003517.pdf.
2 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology- derived proteins as active substance: quality issues (revision 1) (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/05/WC500127960.pdf.
3 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology- derived proteins as active substance: non-clinical and clinical issues (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003920.pdf.
4 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on non- clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2010/04/WC500089474.pdf.
5 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH) (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2011/11/WC500117986.pdf.
6 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2014/04/WC500165988.pdf.
7 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Draft guideline on similar biological medicinal products containing interferon beta (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/01/WC500120652.pdf.
8 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing monoclonal antibodies (Draft).
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/06/WC500128686.pdf.
9 US Food and Drug Administration. Guidance for industry – quality considerations in demonstrating biosimilarity to a reference protein product (Draft Guidance).
www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm291134.pdf.
10 US Food and Drug Administration. Guidance for industry – scientific considerations in demonstrating biosimilarity to a reference product (Draft Guidance).
www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm291128.pdf.
11 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins.
anticipate a consensus to be achieved within industry and between industry and regulatory agencies.
Financial & competing interests disclosure The authors have no other relevant affiliations or financial in- volvement with any organization or entity with a financial inter- est in or financial conflict with the subject matter or materials dis- cussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
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Bioanalysis (2015) 7(3)
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