Similar biological medicinal products currently licensed in the European union - Overview of non-clinical study programs

Biologicals

Volumn 39, Issue 5, 2011, Pages 284-288

  Heim, Hans Karl ^a  

^a Federal Institute for Drugs and Medical Devices   (Germany)

Author keywords

Biosimilar drugs; Erythropoietin; Granulocye colony stimulating factor; Somatropin; Toxicity

Indexed keywords

BIOLOGICAL PRODUCT; FIGRASTIM; FIGRASTIM HEXAL; FIGRASTIM RATIOPHARM; HUMAN GROWTH HORMONE; LOW MOLECULAR WEIGHT HEPARIN; RECOMBINANT ALPHA INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; SIMILAR BIOLOGICAL MEDICINAL PRODUCT; UNCLASSIFIED DRUG;

ANEMIA; ARTICLE; BIOTECHNOLOGICAL PRODUCTION; DRUG APPROVAL; DRUG FORMULATION; DRUG MARKETING; DRUG SCREENING; EUROPE; HUMAN; LICENSING; NEUTROPENIA; NON CLINICAL STUDY; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; TOXICITY TESTING; TYPES OF STUDY;

ANIMALS; CYTOKINES; DRUG EVALUATION, PRECLINICAL; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; LICENSURE; RECOMBINANT PROTEINS;

EID: 80053568732     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.025     Document Type: Article

References (33)

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