Biosimilars entering the clinic without animal studies: A paradigm shift in the European union

mAbs

Volumn 6, Issue 5, 2014, Pages 1155-1162

  Van Aerts, Leon Agjm ^a,b   De Smet, Karen ^b,c   Reichmann, Gabriele ^b,d   Van Der Laan, Jan Willem ^a,b   Schneider, Christian K ^b,e,f  

^a MEDICINES EVALUATION BOARD   (Netherlands)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c Federal Agency for Medicines and Health Products Belgium   (Belgium)

^d PAUL EHRLICH INSTITUT   (Germany)

^e Danish Health and Medicines Authority   (Denmark)

^f INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

Author keywords

Biosimilar; Comparability; Follow on biologicals; Regulatory expectations; Safety

Indexed keywords

BIOSIMILAR AGENT;

BIOASSAY; CLINICAL STUDY; COMPARATIVE STUDY; EUROPE; EUROPEAN UNION; HOSPITAL; HUMAN; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; PHARMACODYNAMICS; PHARMACOKINETICS; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; REVIEW;

EID: 84913540290     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.29848     Document Type: Review

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