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Biosimilar products biosimilars

EMEA (2005a), CHMP. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance quality issues, London. Available at http //www.emea.eu.int/pdfs/human/biosimilar/4934805en.pdf (accessed October 2006). [Pg.369]

Temporary WPs Pediatric (PEG), Similar Biological (Biosimilar) Medicinal Products (BMWP)... [Pg.75]

TABLE 4.6 EU preclinical guidelines on biosimilar medicinal products... [Pg.81]

European Medicines Agency—Committee for Medicinal Products for Human Use. Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance Nonclinical and Clinical Issues. EMEA/ CHMP/42832/05. 22 February 2006. http //www.emea.europa.eu/pdfs/human/ biosimilar/4283205en.pdf... [Pg.92]

Guideline on Similar Biological Medicinal Products, 2005. http //www.emea.europa. eu/pdfs/human/biosimilar/043704en.pdf... [Pg.176]

Committee for Medicinal Products for Human Use (CHMP), 2006. Concept Paper on Guideline on Immunogenicity assessment of Therapeutic Proteins. http //www. emea.eu.int/pdfs/human/biosimilar/24651105en.pdf... [Pg.679]

Animal-based products Marine-based products Tissue engineering Cell therapy Virology Formulations Liposomes/Polymers Biosimilars (Biogenerics)... [Pg.263]

WHO Informal Consultation on INN Pohcy for Biosimilar products http //www.who.int/medicines/serv-ices/inn/inn bio/en/index. html... [Pg.873]

Of probable interest to the reader of this volume are the many applications of SPR to assays for the detection and characterization of antibodies elicited by therapeutic treatment with biologic macromolecules [166 169]. Given the current intense interest in the development of protein and ODN macromolecules as potential therapeutics, as well as the developing interest in biosimilar protein products, immunogenicity of macromolecules will continue to be investigated for the foreseeable future. Further discussion of assay formats for the detection and characterization of antibodies elicited by treatment with macromolecular therapeutics is presented elsewhere in this volume. [Pg.361]

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See also in sourсe #XX -- [ Pg.1457 ]



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