Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges

GaBI Journal

Volumn 4, Issue 1, 2015, Pages 36-41

  Pen, Ally ^a   Klein, Agnes V ^a   Wang, Jian ^a  

^a Health Canada and World Health Organization Collaborating Center for Standardization and Evaluation of Biologicals   (Canada)

Author keywords

Biologicals; Biosimilars; Clinical trials; Extrapolation; Immunogenicity; Regulatory

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; FILGRASTIM; HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN;

ARTICLE; CANADA; CLINICAL TRIAL (TOPIC); DECISION MAKING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DESIGN; DRUG DISPOSITION; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG POTENCY; DRUG PROGRAM; DRUG SAFETY; GROWTH HORMONE DEFICIENCY; HEMATOLOGIC MALIGNANCY; HUMAN; IMMUNOGENICITY; NONHUMAN; PRADER WILLI SYNDROME; PURE RED CELL ANEMIA; RISK MANAGEMENT; TURNER SYNDROME;

EID: 84997798842     PISSN: 20336403     EISSN: 20336772     Source Type: Journal    
DOI: 10.5639/gabij.2015.0401.009     Document Type: Article

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