Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®)

Toxicologic Pathology

Volumn 42, Issue 7, 2014, Pages 1069-1081

  Ryan, Anne M ^a   Sokolowski, Sharon A ^a   Ng, Chee Keng ^a   Shirai, Norimitsu ^a   Collinge, Mark ^a   Shen, Amy C ^a   Arrington, Joshua ^a   Radi, Zaher ^b   Cummings, Thomas R ^a   Ploch, Stephen A ^b   Stephenson, Sarah A ^b   Tripathi, Niraj K ^b   Hurst, Susan I ^a   Finch, Gregory L ^a   Leach, Michael W ^a  

^a PFIZER INC   (United States)

^b 206 Carnegie Center   (United States)

Author keywords

anti CD20; B cells; cynomolgus monkey; monoclonal antibody.; nonclinical safety; potential biosimilar; rituximab

Indexed keywords

BIOSIMILAR AGENT; CD20 ANTIBODY; DRUG ANTIBODY; PF 05280586; RITUXIMAB; UNCLASSIFIED DRUG; CD20 ANTIGEN; MONOCLONAL ANTIBODY;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; B LYMPHOCYTE; COMPLEMENT DEPENDENT CYTOTOXICITY; CONTROLLED STUDY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN CELL; LYMPHOCYTE DEPLETION; MACACA FASCICULARIS; MALE; MULTIPLE CYCLE TREATMENT; NONHUMAN; PEPTIDE MAPPING; REPEATED DRUG DOSE; SINGLE DRUG DOSE; TREATMENT OUTCOME; ANIMAL; BIOASSAY; COMPARATIVE STUDY; DOSE RESPONSE; DRUG EFFECTS; METABOLISM; REPRODUCIBILITY;

ANIMALS; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTIGENS, CD20; B-LYMPHOCYTES; BIOSIMILAR PHARMACEUTICALS; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDPOINT DETERMINATION; FEMALE; MACACA FASCICULARIS; MALE; REPRODUCIBILITY OF RESULTS;

EID: 84907525369     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623313520351     Document Type: Article

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