Regulatory and clinical considerations for biosimilar oncology drugs

The Lancet Oncology

Volumn 15, Issue 13, 2014, Pages e594-e605

  Bennett, C L ^a,b,c   Chen, B ^a   Wyatt, M D ^a   Schulz, R M ^a   Georgantopoulos, P ^a,b   Kessler, S ^a   Qureshi, Z P ^a   Lu, Z K ^a,b,c   Love, B L ^a,b   Noxon, V ^a   Bian, J ^a   Ray, P ^a,i   Ablin, R J ^a,j   Hruskesky, W J ^a,c   Hermanson, T ^d   Raisch, D W ^e   Bobolts, L ^f,g   Armitage, M ^f,h,m   Hrushesky, W J ^f   Macdougall, I C ^k   Sartor, O ^l   Armitage, J O ^m   more..

^a UNIVERSITY OF SOUTH CAROLINA   (United States)

^b WJB Dorn VA Medical Center   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^e UNIVERSITY OF NEW MEXICO   (United States)

^f Oncology Analytics Inc   (United States)

^g NOVA SOUTHEASTERN UNIVERSITY   (United States)

^h UNIVERSITY OF SOUTH FLORIDA   (United States)

ⁱ MIDWESTERN UNIVERSITY   (United States)

^j UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^k KING S COLLEGE HOSPITAL   (United Kingdom)

^l TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA2B INTERFERON; BEVACIZUMAB; BIOSIMILAR AGENT; FILGRASTIM; GLYCINE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PACLITAXEL; PEGFILGRASTIM; PEGINESATIDE; PLACEBO; POLYSORBATE 80; RECOMBINANT ERYTHROPOIETIN; RITUXIMAB; TRASTUZUMAB; UNCLASSIFIED DRUG; XM 02; ANTINEOPLASTIC AGENT;

ADVANCED CANCER; AMINO ACID SEQUENCE; ANAPHYLAXIS; ANEMIA; ASTHENIA; AUSTRALIA; BLOOD CLOTTING DISORDER; BONE PAIN; BRAIN CANCER; BREAST CANCER; BREAST METASTASIS; CANADA; CD34 SELECTION; CEREBROVASCULAR DISEASE; CHINA; CHRONIC KIDNEY DISEASE; CHRONIC LYMPHATIC LEUKEMIA; COLORECTAL CANCER; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; ESCHERICHIA COLI; EUROPE; FEBRILE NEUTROPENIA; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HEMODIALYSIS; HUMAN; HYPOTENSION; IMMUNOGENICITY; INDIA; JAPAN; KIDNEY CANCER; LUNG CANCER; MYALGIA; NEUTROPENIA; NEUTROPHIL COUNT; NON SMALL CELL LUNG CANCER; NONHODGKIN LYMPHOMA; NONHUMAN; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHYSICIAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN GLYCOSYLATION; PROTEIN PHOSPHORYLATION; PURE RED CELL ANEMIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RUSSIAN FEDERATION; SOUTH KOREA; STOMACH ADENOCARCINOMA; THROMBOEMBOLISM; TREATMENT RESPONSE; UNITED STATES; LEGISLATION AND JURISPRUDENCE; NEOPLASMS; STANDARDS;

ANTINEOPLASTIC AGENTS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; HUMANS; NEOPLASMS;

EID: 84924854592     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70365-1     Document Type: Review

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