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Biosimilars

Combe C, Tredree RL, Schellekens H Biosimilar epoetins an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy (2005) 25(7) 954—962. [Pg.207]

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]

See other pages where Biosimilars is mentioned: [Pg.352]    [Pg.353]    [Pg.354]    [Pg.107]    [Pg.92]    [Pg.188]    [Pg.240]    [Pg.11]    [Pg.191]    [Pg.196]    [Pg.196]    [Pg.197]    [Pg.206]    [Pg.3]    [Pg.366]    [Pg.366]    [Pg.367]    [Pg.369]    [Pg.369]    [Pg.530]    [Pg.6]    [Pg.15]    [Pg.68]    [Pg.76]    [Pg.80]    [Pg.88]    [Pg.92]    [Pg.92]    [Pg.92]    [Pg.164]    [Pg.165]    [Pg.435]    [Pg.435]    [Pg.680]    [Pg.13]    [Pg.18]   
See also in sourсe #XX -- [ Pg.227 ]

See also in sourсe #XX -- [ Pg.228 ]



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