Biosimilars: A Multidisciplinary Perspective

Abstract A biosimilar is an officially regulated and approved copy of an originator biologic therapy. Improved affordability and consequent wider patient access compared with biologics are a significant appeal of biosimilars. Regulatory guidelines for biosimilar development and approval are rigorous...

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Veröffentlicht in:	Clinical therapeutics 2016-05, Vol.38 (5), p.1238-1249
Hauptverfasser:	Khraishi, Majed, MB, BCh, FRCPC, Stead, David, GPhC, MRPharmS, DMS, Lukas, Milan, MD, PhD, Scotte, Florian, MD, PhD, Schmid, Holger, MD, MSc
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies, Monoclonal - therapeutic use arthritis Biological activity Biological products Biosimilar Pharmaceuticals - therapeutic use biosimilars Blood transfusions Chemotherapy Clinical medicine Dwarfism Europe FDA approval Gangrene Genetic disorders Growth hormones Humans In vitro fertilization Inflammatory Bowl Disease (IBD) Internal Medicine Manufacturing Medical Education Names Nephrology Neutropenia Pharmaceutical industry Pharmacovigilance Protein folding Quality Risk Assessment safety Studies Tumor necrosis factor-TNF
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