Regulatory considerations in oncologic biosimilar drug development

mAbs

Volumn 7, Issue 4, 2015, Pages 653-661

  Macdonald, Judith C ^a   Hartman, Helen ^b   Jacobs, Ira A ^b  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b PFIZER INC   (United States)

Author keywords

Biologics; Biosimilars; Interchangeability; Labeling; Naming; Regulatory

Indexed keywords

BIOSIMILAR AGENT; MONOCLONAL ANTIBODY; ANTINEOPLASTIC AGENT; CANCER ANTIBODY;

CLINICAL PRACTICE; DRUG DESIGN; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG SAFETY; HEALTH CARE POLICY; MEDICINAL CHEMISTRY; ONCOLOGIST; ONCOLOGY; PHARMACY; PRACTICE GUIDELINE; PRESCRIPTION; REVIEW; WORLD HEALTH ORGANIZATION; DRUG APPROVAL; DRUG LEGISLATION; HUMAN;

ANTIBODIES, MONOCLONAL; ANTIBODIES, NEOPLASM; ANTINEOPLASTIC AGENTS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; HUMANS; LEGISLATION, DRUG;

EID: 84941560552     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2015.1040973     Document Type: Review

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