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Volumn 12, Issue 5, 2017, Pages 599-610

Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars

Author keywords

[No Author keywords available]

Indexed keywords

ABP 215; ADALIMUMAB; BCD 021; BEVACIZUMAB; BEVZ 92; BI 695502; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CAPECITABINE; CARBOPLATIN; CBT 124; ETANERCEPT; FILGRASTIM; FKB 238; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; INFLIXIMAB; IRINOTECAN; MITOMYCIN; OXALIPLATIN; PACLITAXEL; PF 06439535; PLACEBO; RECOMBINANT ERYTHROPOIETIN; RITUXIMAB; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2; IMMUNOLOGICAL ANTINEOPLASTIC AGENT;

EID: 85027296561     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-017-0518-1     Document Type: Review
Times cited : (121)

References (74)
  • 1
    • 85029955366 scopus 로고    scopus 로고
    • World Health Organization. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. World fact sheet. 2012 (last
    • Accessed 8 Sept 2016, International Agency for Research on Cancer
    • International Agency for Research on Cancer, World Health Organization. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. World fact sheet. 2012 (last update 2012). http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Accessed 8 Sept 2016
    • (2012) update
  • 2
    • 84899628178 scopus 로고    scopus 로고
    • Colorectal cancer
    • PID: 24225001
    • Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014;383:1490–502. doi:10.1016/S0140-6736(13)61649-9.
    • (2014) Lancet , vol.383 , pp. 1490-1502
    • Brenner, H.1    Kloor, M.2    Pox, C.P.3
  • 4
    • 84911474269 scopus 로고    scopus 로고
    • Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up
    • PID: 25190710
    • Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25:iii1–9. doi:10.1093/annonc/mdu260.
    • (2014) Ann Oncol , vol.25 , pp. iii1-iii9
    • Van Cutsem, E.1    Cervantes, A.2    Nordlinger, B.3    Arnold, D.4
  • 5
    • 84984985398 scopus 로고    scopus 로고
    • ESMO consensus guidelines for the management of patients with metastatic colorectal cancer
    • PID: 27380959
    • Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27:1386–422. doi:10.1093/annonc/mdw235.
    • (2016) Ann Oncol , vol.27 , pp. 1386-1422
    • Van Cutsem, E.1    Cervantes, A.2    Adam, R.3    Sobrero, A.4    Van Krieken, J.H.5    Aderka, D.6
  • 6
    • 84923306691 scopus 로고    scopus 로고
    • Selection of biologics for patients with metastatic colorectal cancer: the role of predictive markers
    • COI: 1:CAS:528:DC%2BC2MXivFWit7Y%3D, PID: 25579664
    • Kasi PM, Hubbard JM, Grothey A. Selection of biologics for patients with metastatic colorectal cancer: the role of predictive markers. Expert Rev Gastroenterol Hepatol. 2015;9:273–6. doi:10.1586/17474124.2015.1001743.
    • (2015) Expert Rev Gastroenterol Hepatol , vol.9 , pp. 273-276
    • Kasi, P.M.1    Hubbard, J.M.2    Grothey, A.3
  • 7
    • 77955267882 scopus 로고    scopus 로고
    • Roche Registration Limited. Avastin (bevacizumab) summary of product characteristics. 2009 (last update 10/19/2016). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000582/WC500029271.pdf Accessed 21 Oct 2016.
    • (2009) Avastin (bevacizumab) summary of product characteristics
  • 8
    • 85019788375 scopus 로고    scopus 로고
    • Genentech Inc. Avastin® (bevacizumab) prescribing information. 2004 (last update 2016). https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125085s317lbl.pdf Accessed 16 May 2017.
    • (2016) Avastin® (bevacizumab) prescribing information
  • 9
    • 84984984313 scopus 로고    scopus 로고
    • ESMO European consortium study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe
    • COI: 1:STN:280:DC%2BC2s3jvFyjtQ%3D%3D, PID: 27457309
    • Cherny N, Sullivan R, Torode J, Saar M, Eniu A. ESMO European consortium study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe. Ann Oncol. 2016;27:1423–43. doi:10.1093/annonc/mdw213.
    • (2016) Ann Oncol , vol.27 , pp. 1423-1443
    • Cherny, N.1    Sullivan, R.2    Torode, J.3    Saar, M.4    Eniu, A.5
  • 10
    • 84900407291 scopus 로고    scopus 로고
    • Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey
    • COI: 1:CAS:528:DC%2BC2cXhs1Cqt7zK
    • Baer WH, Maini A, Jacobs I. Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (Basel). 2014;7:530–44. doi:10.3390/ph7050530.
    • (2014) Pharmaceuticals (Basel) , vol.7 , pp. 530-544
    • Baer, W.H.1    Maini, A.2    Jacobs, I.3
  • 11
    • 84928107043 scopus 로고    scopus 로고
    • Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets
    • COI: 1:CAS:528:DC%2BC2MXisFSis7o%3D
    • Lammers P, Criscitiello C, Curigliano G, Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals (Basel). 2014;7:943–53. doi:10.3390/ph7090943.
    • (2014) Pharmaceuticals (Basel) , vol.7 , pp. 943-953
    • Lammers, P.1    Criscitiello, C.2    Curigliano, G.3    Jacobs, I.4
  • 12
    • 85011556605 scopus 로고    scopus 로고
    • Barriers to the access of bevacizumab in patients with solid tumors and the potential impact of biosimilars: a physician survey
    • Monk BJ, Lammers PE, Cartwright T, Jacobs I. Barriers to the access of bevacizumab in patients with solid tumors and the potential impact of biosimilars: a physician survey. Pharmaceuticals (Basel). 2017. doi:10.3390/ph10010019.
    • (2017) Pharmaceuticals (Basel)
    • Monk, B.J.1    Lammers, P.E.2    Cartwright, T.3    Jacobs, I.4
  • 13
    • 2542561964 scopus 로고    scopus 로고
    • Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer
    • COI: 1:CAS:528:DC%2BD2cXks1Gjt74%3D, PID: 15175435
    • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335–42. doi:10.1056/NEJMoa032691.
    • (2004) N Engl J Med , vol.350 , pp. 2335-2342
    • Hurwitz, H.1    Fehrenbacher, L.2    Novotny, W.3    Cartwright, T.4    Hainsworth, J.5    Heim, W.6
  • 14
    • 34248173883 scopus 로고    scopus 로고
    • Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200
    • COI: 1:CAS:528:DC%2BD2sXlsVyntbc%3D, PID: 17442997
    • Giantonio BJ, Catalano PJ, Meropol NJ, O’Dwyer PJ, Mitchell EP, Alberts SR, et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007;25:1539–44. doi:10.1200/JCO.2006.09.6305.
    • (2007) J Clin Oncol , vol.25 , pp. 1539-1544
    • Giantonio, B.J.1    Catalano, P.J.2    Meropol, N.J.3    O’Dwyer, P.J.4    Mitchell, E.P.5    Alberts, S.R.6
  • 15
    • 84871720057 scopus 로고    scopus 로고
    • Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial
    • COI: 1:CAS:528:DC%2BC3sXhsV2gug%3D%3D, PID: 23168366
    • Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, et al. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013;14:29–37. doi:10.1016/S1470-2045(12)70477-1.
    • (2013) Lancet Oncol , vol.14 , pp. 29-37
    • Bennouna, J.1    Sastre, J.2    Arnold, D.3    Osterlund, P.4    Greil, R.5    Van Cutsem, E.6
  • 16
    • 84884700039 scopus 로고    scopus 로고
    • Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial
    • COI: 1:CAS:528:DC%2BC3sXhsVOnsLbP, PID: 24028813
    • Cunningham D, Lang I, Marcuello E, Lorusso V, Ocvirk J, Shin DB, et al. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013;14:1077–85. doi:10.1016/S1470-2045(13)70154-2.
    • (2013) Lancet Oncol , vol.14 , pp. 1077-1085
    • Cunningham, D.1    Lang, I.2    Marcuello, E.3    Lorusso, V.4    Ocvirk, J.5    Shin, D.B.6
  • 17
    • 80054779014 scopus 로고    scopus 로고
    • Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial
    • Guan ZZ, Xu JM, Luo RC, Feng FY, Wang LW, Shen L, et al. Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial. Chin J Cancer Res. 2011;30:682–9. doi:10.5732/cjc.011.10188.
    • (2011) Chin J Cancer Res , vol.30 , pp. 682-689
    • Guan, Z.Z.1    Xu, J.M.2    Luo, R.C.3    Feng, F.Y.4    Wang, L.W.5    Shen, L.6
  • 18
    • 0037208589 scopus 로고    scopus 로고
    • Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer
    • COI: 1:CAS:528:DC%2BD2cXpsVWru7Y%3D, PID: 12506171
    • Kabbinavar F, Hurwitz HI, Fehrenbacher L, Meropol NJ, Novotny WF, Lieberman G, et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol. 2003;21:60–5. doi:10.1200/JCO.2003.10.066.
    • (2003) J Clin Oncol , vol.21 , pp. 60-65
    • Kabbinavar, F.1    Hurwitz, H.I.2    Fehrenbacher, L.3    Meropol, N.J.4    Novotny, W.F.5    Lieberman, G.6
  • 19
    • 20544478429 scopus 로고    scopus 로고
    • Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial
    • COI: 1:CAS:528:DC%2BD2MXlslWntr0%3D, PID: 15738537
    • Kabbinavar FF, Schulz J, McCleod M, Patel T, Hamm JT, Hecht JR, et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J Clin Oncol. 2005;23:3697–705. doi:10.1200/JCO.2005.05.112.
    • (2005) J Clin Oncol , vol.23 , pp. 3697-3705
    • Kabbinavar, F.F.1    Schulz, J.2    McCleod, M.3    Patel, T.4    Hamm, J.T.5    Hecht, J.R.6
  • 20
    • 84938095204 scopus 로고    scopus 로고
    • Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial
    • COI: 1:STN:280:DC%2BC2Mngs1elsQ%3D%3D, PID: 25735317
    • Passardi A, Nanni O, Tassinari D, Turci D, Cavanna L, Fontana A, et al. Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial. Ann Oncol. 2015;26:1201–7. doi:10.1093/annonc/mdv130.
    • (2015) Ann Oncol , vol.26 , pp. 1201-1207
    • Passardi, A.1    Nanni, O.2    Tassinari, D.3    Turci, D.4    Cavanna, L.5    Fontana, A.6
  • 21
    • 42949149159 scopus 로고    scopus 로고
    • Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study
    • COI: 1:CAS:528:DC%2BD1cXlvFaqs7g%3D, PID: 18421054
    • Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26:2013–9. doi:10.1200/JCO.2007.14.9930.
    • (2008) J Clin Oncol , vol.26 , pp. 2013-2019
    • Saltz, L.B.1    Clarke, S.2    Diaz-Rubio, E.3    Scheithauer, W.4    Figer, A.5    Wong, R.6
  • 22
    • 77956083776 scopus 로고    scopus 로고
    • Treatment of colorectal cancer with and without bevacizumab: a phase III study
    • COI: 1:CAS:528:DC%2BC3cXhtFGhtLvO, PID: 20798560
    • Stathopoulos GP, Batziou C, Trafalis D, Koutantos J, Batzios S, Stathopoulos J, et al. Treatment of colorectal cancer with and without bevacizumab: a phase III study. Oncology. 2010;78:376–81. doi:10.1159/000320520.
    • (2010) Oncology , vol.78 , pp. 376-381
    • Stathopoulos, G.P.1    Batziou, C.2    Trafalis, D.3    Koutantos, J.4    Batzios, S.5    Stathopoulos, J.6
  • 23
    • 77955497309 scopus 로고    scopus 로고
    • Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study
    • COI: 1:CAS:528:DC%2BC3cXpslajtL0%3D, PID: 20516443
    • Tebbutt NC, Wilson K, Gebski VJ, Cummins MM, Zannino D, van Hazel GA, et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. J Clin Oncol. 2010;28:3191–8. doi:10.1200/JCO.2009.27.7723.
    • (2010) J Clin Oncol , vol.28 , pp. 3191-3198
    • Tebbutt, N.C.1    Wilson, K.2    Gebski, V.J.3    Cummins, M.M.4    Zannino, D.5    van Hazel, G.A.6
  • 24
    • 85007477166 scopus 로고    scopus 로고
    • Efficacy and safety of bevacizumab plus chemotherapy compared to chemotherapy alone in previously untreated advanced or metastatic colorectal cancer: a systematic review and meta-analysis
    • PID: 27558497
    • Botrel TE, Clark LG, Paladini L, Clark OA. Efficacy and safety of bevacizumab plus chemotherapy compared to chemotherapy alone in previously untreated advanced or metastatic colorectal cancer: a systematic review and meta-analysis. BMC Cancer. 2016;16:677. doi:10.1186/s12885-016-2734-y.
    • (2016) BMC Cancer , vol.16 , pp. 677
    • Botrel, T.E.1    Clark, L.G.2    Paladini, L.3    Clark, O.A.4
  • 25
    • 84928398302 scopus 로고    scopus 로고
    • Value of bevacizumab in treatment of colorectal cancer: a meta-analysis
    • COI: 1:CAS:528:DC%2BC2MXhtVGhtr7E, PID: 25945023
    • Qu CY, Zheng Y, Zhou M, Zhang Y, Shen F, Cao J, et al. Value of bevacizumab in treatment of colorectal cancer: a meta-analysis. World J Gastroenterol. 2015;21:5072–80. doi:10.3748/wjg.v21.i16.5072.
    • (2015) World J Gastroenterol , vol.21 , pp. 5072-5080
    • Qu, C.Y.1    Zheng, Y.2    Zhou, M.3    Zhang, Y.4    Shen, F.5    Cao, J.6
  • 26
    • 84926476833 scopus 로고    scopus 로고
    • Continuation or reintroduction of bevacizumab beyond progression to first-line therapy in metastatic colorectal cancer: final results of the randomized BEBYP trial
    • COI: 1:STN:280:DC%2BC2MvnsFOisw%3D%3D, PID: 25600568
    • Masi G, Salvatore L, Boni L, Loupakis F, Cremolini C, Fornaro L, et al. Continuation or reintroduction of bevacizumab beyond progression to first-line therapy in metastatic colorectal cancer: final results of the randomized BEBYP trial. Ann Oncol. 2015;26:724–30. doi:10.1093/annonc/mdv012.
    • (2015) Ann Oncol , vol.26 , pp. 724-730
    • Masi, G.1    Salvatore, L.2    Boni, L.3    Loupakis, F.4    Cremolini, C.5    Fornaro, L.6
  • 27
    • 84860169991 scopus 로고    scopus 로고
    • Bevacizumab-based therapies in the first-line treatment of metastatic colorectal cancer
    • COI: 1:CAS:528:DC%2BC38XptFWrtbk%3D, PID: 22477726
    • Strickler JH, Hurwitz HI. Bevacizumab-based therapies in the first-line treatment of metastatic colorectal cancer. Oncologist. 2012;17:513–24. doi:10.1634/theoncologist.2012-0003.
    • (2012) Oncologist , vol.17 , pp. 513-524
    • Strickler, J.H.1    Hurwitz, H.I.2
  • 28
    • 84893682324 scopus 로고    scopus 로고
    • Bevacizumab in elderly patients with metastatic colorectal cancer
    • PID: 24484722
    • Sclafani F, Cunningham D. Bevacizumab in elderly patients with metastatic colorectal cancer. J Geriatr Oncol. 2014;5:78–88. doi:10.1016/j.jgo.2013.08.006.
    • (2014) J Geriatr Oncol , vol.5 , pp. 78-88
    • Sclafani, F.1    Cunningham, D.2
  • 29
    • 84961035436 scopus 로고    scopus 로고
    • Maintenance therapy for metastatic colorectal cancer
    • PID: 26474519
    • Ciardiello F. Maintenance therapy for metastatic colorectal cancer. Lancet Oncol. 2015;16:1444–5. doi:10.1016/S1470-2045(15)00308-3.
    • (2015) Lancet Oncol , vol.16 , pp. 1444-1445
    • Ciardiello, F.1
  • 30
    • 79959338988 scopus 로고    scopus 로고
    • Survival for metastatic colorectal cancer in the bevacizumab era: a population-based analysis
    • COI: 1:CAS:528:DC%2BC3MXhtlKju7nE, PID: 21859560
    • Renouf DJ, Lim HJ, Speers C, Villa D, Gill S, Blanke CD, et al. Survival for metastatic colorectal cancer in the bevacizumab era: a population-based analysis. Clin Colorectal Cancer. 2011;10:97–101. doi:10.1016/j.clcc.2011.03.004.
    • (2011) Clin Colorectal Cancer , vol.10 , pp. 97-101
    • Renouf, D.J.1    Lim, H.J.2    Speers, C.3    Villa, D.4    Gill, S.5    Blanke, C.D.6
  • 31
    • 84958054447 scopus 로고    scopus 로고
    • Survival improvements associated with access to biological agents: results from the south Australian (SA) metastatic colorectal cancer (mCRC) registry
    • COI: 1:CAS:528:DC%2BC28XivVGmu70%3D, PID: 26878155
    • Tomita Y, Karapetis CS, Ullah S, Townsend AR, Roder D, Beeke C, et al. Survival improvements associated with access to biological agents: results from the south Australian (SA) metastatic colorectal cancer (mCRC) registry. Acta Oncol. 2016;55:480–5. doi:10.3109/0284186X.2015.1117135.
    • (2016) Acta Oncol , vol.55 , pp. 480-485
    • Tomita, Y.1    Karapetis, C.S.2    Ullah, S.3    Townsend, A.R.4    Roder, D.5    Beeke, C.6
  • 32
    • 84867915756 scopus 로고    scopus 로고
    • Less than ideal: how oncologists practice with limited drug access
    • PID: 22942815
    • Chan KK, Wong B, Siu LL, Straus SE, Chang J, Berry SR. Less than ideal: how oncologists practice with limited drug access. J Oncol Pract. 2012;8:190–5. doi:10.1200/JOP.2011.000337.
    • (2012) J Oncol Pract , vol.8 , pp. 190-195
    • Chan, K.K.1    Wong, B.2    Siu, L.L.3    Straus, S.E.4    Chang, J.5    Berry, S.R.6
  • 33
    • 84892578954 scopus 로고    scopus 로고
    • Hospital management of outpatient oncology treatment decisions: a survey to identify strategies and concerns
    • PID: 23943887
    • Li E, Schleif R, Edelen B. Hospital management of outpatient oncology treatment decisions: a survey to identify strategies and concerns. J Oncol Pract. 2013;9:e248–54. doi:10.1200/JOP.2012.000814.
    • (2013) J Oncol Pract , vol.9 , pp. e248-e254
    • Li, E.1    Schleif, R.2    Edelen, B.3
  • 34
    • 32944472716 scopus 로고    scopus 로고
    • Do oncologists believe new cancer drugs offer good value?
    • PID: 16476830
    • Nadler E, Eckert B, Neumann PJ. Do oncologists believe new cancer drugs offer good value? Oncologist. 2006;11:90–5. doi:10.1634/theoncologist.11-2-90.
    • (2006) Oncologist , vol.11 , pp. 90-95
    • Nadler, E.1    Eckert, B.2    Neumann, P.J.3
  • 36
    • 84908570727 scopus 로고    scopus 로고
    • Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales
    • Chamberlain C, Collin SM, Stephens P, Donovan J, Bahl A, Hollingworth W. Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales. Br J Cancer. 2014;111:1693–702. doi:10.1038/bjc.2014.86.
    • (2014) Br J Cancer , vol.111 , pp. 1693-1702
    • Chamberlain, C.1    Collin, S.M.2    Stephens, P.3    Donovan, J.4    Bahl, A.5    Hollingworth, W.6
  • 37
    • 84924595684 scopus 로고    scopus 로고
    • NHS England. National cancer drugs fund list. 2015 (last update 11/4/2015). http://webarchive.nationalarchives.gov.uk/20151223153822/https://www.england.nhs.uk/wp-content/uploads/2015/11/ncdf-list-nov-15.pdf Accessed 20 Jan 2017.
    • (2015) National cancer drugs fund list
  • 38
    • 84869182547 scopus 로고    scopus 로고
    • Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal
    • PID: 23058097
    • Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30:1119–32. doi:10.2165/11597210-000000000-00000.
    • (2012) Pharmacoeconomics , vol.30 , pp. 1119-1132
    • Whyte, S.1    Pandor, A.2    Stevenson, M.3
  • 41
    • 84928829480 scopus 로고    scopus 로고
    • After counterfeit Avastin®--what have we learned and what can be done?
    • COI: 1:CAS:528:DC%2BC2MXjvFWks70%3D, PID: 25734637
    • Mackey TK, Cuomo R, Guerra C, Liang BA. After counterfeit Avastin®--what have we learned and what can be done? Nat Rev Clin Oncol. 2015;12:302–8. doi:10.1038/nrclinonc.2015.35.
    • (2015) Nat Rev Clin Oncol , vol.12 , pp. 302-308
    • Mackey, T.K.1    Cuomo, R.2    Guerra, C.3    Liang, B.A.4
  • 42
    • 84975297677 scopus 로고    scopus 로고
    • Patterns of biologics use across treatment lines in elderly (age >65) Medicare patients with metastatic colon cancer
    • PID: 27125751
    • Bikov KA, Mullins CD, Hung A, Seal B, Onukwugha E, Hanna N. Patterns of biologics use across treatment lines in elderly (age >65) Medicare patients with metastatic colon cancer. Oncologist. 2016;21:676–83. doi:10.1634/theoncologist.2015-0199.
    • (2016) Oncologist , vol.21 , pp. 676-683
    • Bikov, K.A.1    Mullins, C.D.2    Hung, A.3    Seal, B.4    Onukwugha, E.5    Hanna, N.6
  • 43
    • 84903376694 scopus 로고    scopus 로고
    • The health and economic effects of counterfeit drugs
    • PID: 25126373
    • Blackstone EA, Fuhr Jr JP, Pociask S. The health and economic effects of counterfeit drugs. Am Health Drug Benefits. 2014;7:216–24.
    • (2014) Am Health Drug Benefits , vol.7 , pp. 216-224
    • Blackstone, E.A.1    Fuhr, J.P.2    Pociask, S.3
  • 44
    • 84933678890 scopus 로고    scopus 로고
    • The economics of counterfeit Avastin: a geospatial and statistical analysis of demographic correlates to FDA warning letters
    • COI: 1:CAS:528:DC%2BC2MXhtFCiu7fK, PID: 26016718
    • Cuomo RE, Mackey TK, Stigler P. The economics of counterfeit Avastin: a geospatial and statistical analysis of demographic correlates to FDA warning letters. Pharmacoepidemiol Drug Saf. 2015;24:748–56. doi:10.1002/pds.3796.
    • (2015) Pharmacoepidemiol Drug Saf , vol.24 , pp. 748-756
    • Cuomo, R.E.1    Mackey, T.K.2    Stigler, P.3
  • 45
    • 85029957305 scopus 로고    scopus 로고
    • Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015 (last
    • Accessed 10 June 2016, US Food and Drug Administration
    • US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015 (last update 4/2015). http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf Accessed 10 June 2016.
    • (2015) update , vol.4
  • 46
    • 85029915600 scopus 로고    scopus 로고
    • The impact of biosimilar competition. 2016 (last
    • Accessed 19 Sept 2016
    • IMS Health. The impact of biosimilar competition. 2016 (last update 6/2016). http://ec.europa.eu/DocsRoom/documents/17325/attachments/1/translations/en/renditions/native Accessed 19 Sept 2016.
    • (2016) update , vol.6
    • Health, I.M.S.1
  • 47
    • 84954449240 scopus 로고    scopus 로고
    • Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor
    • PID: 26780505
    • Pettengell R, Bias P, Mueller U, Lang N. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor. Support Care Cancer. 2016;24:2677–84. doi:10.1007/s00520-015-3057-2.
    • (2016) Support Care Cancer , vol.24 , pp. 2677-2684
    • Pettengell, R.1    Bias, P.2    Mueller, U.3    Lang, N.4
  • 48
    • 84884283941 scopus 로고    scopus 로고
    • Clinical experience with Zarzio(R) in Europe: what have we learned?
    • PID: 23903799
    • Gascón P, Tesch H, Verpoort K, Rosati MS, Salesi N, Agrawal S, et al. Clinical experience with Zarzio(R) in Europe: what have we learned? Support Care Cancer. 2013;21:2925–32. doi:10.1007/s00520-013-1911-7.
    • (2013) Support Care Cancer , vol.21 , pp. 2925-2932
    • Gascón, P.1    Tesch, H.2    Verpoort, K.3    Rosati, M.S.4    Salesi, N.5    Agrawal, S.6
  • 51
    • 84966283006 scopus 로고    scopus 로고
    • European Medicines Agency. Guideline on similar biological medicinal products. 2014 (last update 4/30/2015). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf Accessed 9 June 2016.
    • (2014) Guideline on similar biological medicinal products
  • 53
    • 84911401436 scopus 로고    scopus 로고
    • Biosimilars: the science of extrapolation
    • COI: 1:CAS:528:DC%2BC2cXitVSgs7zK, PID: 25298038
    • Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124:3191–6. doi:10.1182/blood-2014-06-583617.
    • (2014) Blood , vol.124 , pp. 3191-3196
    • Weise, M.1    Kurki, P.2    Wolff-Holz, E.3    Bielsky, M.C.4    Schneider, C.K.5
  • 57
    • 20044375603 scopus 로고    scopus 로고
    • Biological activity of bevacizumab, a humanized anti-VEGF antibody in vitro
    • COI: 1:CAS:528:DC%2BD2MXktVajtL4%3D, PID: 15886877
    • Wang Y, Fei D, Vanderlaan M, Song A. Biological activity of bevacizumab, a humanized anti-VEGF antibody in vitro. Angiogenesis. 2004;7:335–45. doi:10.1007/s10456-004-8272-2.
    • (2004) Angiogenesis , vol.7 , pp. 335-345
    • Wang, Y.1    Fei, D.2    Vanderlaan, M.3    Song, A.4
  • 58
    • 0032530717 scopus 로고    scopus 로고
    • VEGF and the Fab fragment of a humanized neutralizing antibody: crystal structure of the complex at 2.4 a resolution and mutational analysis of the interface
    • COI: 1:CAS:528:DyaK1cXmsVKjt7Y%3D, PID: 9753694
    • Muller YA, Chen Y, Christinger HW, Li B, Cunningham BC, Lowman HB, et al. VEGF and the Fab fragment of a humanized neutralizing antibody: crystal structure of the complex at 2.4 a resolution and mutational analysis of the interface. Structure. 1998;6:1153–67.
    • (1998) Structure , vol.6 , pp. 1153-1167
    • Muller, Y.A.1    Chen, Y.2    Christinger, H.W.3    Li, B.4    Cunningham, B.C.5    Lowman, H.B.6
  • 60
    • 84966265962 scopus 로고    scopus 로고
    • Nonclinical development of PF-06439535, a potential biosimilar to bevacizumab
    • Rule K, Peraza M, Shiue M, Finch G, Thibault S, Rosenberg JA, et al. Nonclinical development of PF-06439535, a potential biosimilar to bevacizumab. J Thorac Oncol. 2015;10 suppl 2:S485.
    • (2015) J Thorac Oncol , vol.10 , pp. S485
    • Rule, K.1    Peraza, M.2    Shiue, M.3    Finch, G.4    Thibault, S.5    Rosenberg, J.A.6
  • 61
    • 85029940150 scopus 로고    scopus 로고
    • Functional similarity and human pharmacokinetic (PK) equivalence of ABP 215 and bevacizumab
    • Markus R, Born T, Chow V, Zhang N, Huynh Q, Maher G, et al. ;33:(Suppl.) [e14659]
    • Markus R, Born T, Chow V, Zhang N, Huynh Q, Maher G, et al. Functional similarity and human pharmacokinetic (PK) equivalence of ABP 215 and bevacizumab. J Clin Oncol. 2015;33:(Suppl.) [abstract e14659].
    • (2015) J Clin Oncol
  • 62
    • 85054513034 scopus 로고    scopus 로고
    • Randomized, double-blind, phase 3 study evaluating efficacy and safety of ABP 215 compared with bevacizumab in patients with non-squamous NSCLC
    • Thatcher N, Thomas M, Paz-Ares L, Ostoros G, Pan Z, Goldschmidt JH, et al. ;34:(Suppl.) [abstract 9095]
    • Thatcher N, Thomas M, Paz-Ares L, Ostoros G, Pan Z, Goldschmidt JH, et al. Randomized, double-blind, phase 3 study evaluating efficacy and safety of ABP 215 compared with bevacizumab in patients with non-squamous NSCLC. J Clin Oncol. 2016;34:(Suppl.) [abstract 9095].
    • (2016) J Clin Oncol
  • 63
    • 85084273610 scopus 로고    scopus 로고
    • Secondary efficacy results from a phase 3 study comparing efficacy and safety of biosimilar candidate ABP 215 with bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC)
    • Thatcher N, Thomas M, Ostoros G, Pan Z, Goldschmidt JH, Hanes V. Secondary efficacy results from a phase 3 study comparing efficacy and safety of biosimilar candidate ABP 215 with bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC). Ann Oncol. 2016;27:vi411–5. doi:10.1093/annonc/mdw382.10.
    • (2016) Ann Oncol , vol.27 , pp. vi411-vi415
    • Thatcher, N.1    Thomas, M.2    Ostoros, G.3    Pan, Z.4    Goldschmidt, J.H.5    Hanes, V.6
  • 64
    • 84924722447 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients
    • Orlov SV, Burdaeva ON, Nachaeva MP, Kopp MV, Kotiv BN, Sheveleva LP, et al. ;32:(Suppl.) [abstract e13500]
    • Orlov SV, Burdaeva ON, Nachaeva MP, Kopp MV, Kotiv BN, Sheveleva LP, et al. Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients. J Clin Oncol. 2014;32:(Suppl.) [abstract e13500].
    • (2014) J Clin Oncol
  • 65
    • 85029942935 scopus 로고    scopus 로고
    • Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC
    • Filon O, Orlov S, Burdaeva O, Kopp MV, Kotiv B, Alekseev S, et al. ;33:(Suppl.) [abstract 8057]
    • Filon O, Orlov S, Burdaeva O, Kopp MV, Kotiv B, Alekseev S, et al. Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC. J Clin Oncol. 2015;33:(Suppl.) [abstract 8057].
    • (2015) J Clin Oncol
  • 66
    • 85029932063 scopus 로고    scopus 로고
    • randomized, single-blind, phase I trial (INVICTAN®-1) assessing the pharmacokinetic bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. 2016 (last
    • Accessed 18 Jan 2017
    • Hettema W, Wynne C, Schliephake D, Lang B, Altendorfer M, Czeloth N. A randomized, single-blind, phase I trial (INVICTAN®-1) assessing the pharmacokinetic bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. 2016 (last update 11/2016). http://abstracts.aaps.org/Verify/AAPS2016/PosterSubmissions/08W1230.pdf Accessed 18 Jan 2017.
    • (2016) update , vol.11
    • Hettema, W.1    Wynne, C.2    Schliephake, D.3    Lang, B.4    Altendorfer, M.5    Czeloth, N.A.6
  • 67
    • 84961214920 scopus 로고    scopus 로고
    • A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers
    • COI: 1:CAS:528:DC%2BC28Xks1OrtLo%3D, PID: 26984210
    • Knight B, Rassam D, Liao S, Ewesuedo R. A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers. Cancer Chemother Pharmacol. 2016;77:839–46. doi:10.1007/s00280-016-3001-2.
    • (2016) Cancer Chemother Pharmacol , vol.77 , pp. 839-846
    • Knight, B.1    Rassam, D.2    Liao, S.3    Ewesuedo, R.4
  • 68
    • 85029919278 scopus 로고    scopus 로고
    • Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Guidance for industry. 2016 (last
    • Accessed 30 Jan 2017, US Food and Drug Administration
    • US Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Guidance for industry. 2016 (last update 12/2016). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf Accessed 30 Jan 2017.
    • (2016) update , vol.12
  • 69
    • 85029947713 scopus 로고    scopus 로고
    • Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). 2016 (last
    • Accessed 12 Apr 2017, World Health Organization
    • World Health Organization. Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). 2016 (last update 10/2016). http://www.who.int/biologicals/expert_committee/mAb_SBP_GL-ECBS_review_adoption-2016.10.26-11.7post_ECBS-Clean_Version.pdf?ua=1 Accessed 12 Apr 2017.
    • (2016) update , vol.10
  • 70
    • 84954338760 scopus 로고    scopus 로고
    • Statistical primer on biosimilar clinical development
    • PID: 26766293
    • Isakov L, Jin B, Jacobs IA. Statistical primer on biosimilar clinical development. Am J Ther. 2016;23:e1903–e10. doi:10.1097/MJT.0000000000000391.
    • (2016) Am J Ther , vol.23 , pp. e1903-e1910
    • Isakov, L.1    Jin, B.2    Jacobs, I.A.3
  • 71
    • 84904069611 scopus 로고    scopus 로고
    • The challenge of indication extrapolation for infliximab biosimilars
    • COI: 1:CAS:528:DC%2BC2cXhtVaktb%2FM, PID: 24962198
    • Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42:177–83. doi:10.1016/j.biologicals.2014.05.005.
    • (2014) Biologicals , vol.42 , pp. 177-183
    • Feagan, B.G.1    Choquette, D.2    Ghosh, S.3    Gladman, D.D.4    Ho, V.5    Meibohm, B.6
  • 72
    • 85010016463 scopus 로고    scopus 로고
    • Biosimilars: the US regulatory framework
    • COI: 1:CAS:528:DC%2BC28XhslyksLfE, PID: 27813877
    • Christl LA, Woodcock J, Kozlowski S. Biosimilars: the US regulatory framework. Annu Rev Med. 2017;68:243–54. doi:10.1146/annurev-med-051215-031022.
    • (2017) Annu Rev Med , vol.68 , pp. 243-254
    • Christl, L.A.1    Woodcock, J.2    Kozlowski, S.3
  • 73
    • 84975219820 scopus 로고    scopus 로고
    • Population pharmacokinetics of bevacizumab in cancer patients with external validation
    • COI: 1:CAS:528:DC%2BC28XhtVOisbfP, PID: 27329360
    • Han K, Peyret T, Marchand M, Quartino A, Gosselin NH, Girish S, et al. Population pharmacokinetics of bevacizumab in cancer patients with external validation. Cancer Chemother Pharmacol. 2016;78:341–51. doi:10.1007/s00280-016-3079-6.
    • (2016) Cancer Chemother Pharmacol , vol.78 , pp. 341-351
    • Han, K.1    Peyret, T.2    Marchand, M.3    Quartino, A.4    Gosselin, N.H.5    Girish, S.6
  • 74
    • 85014360186 scopus 로고    scopus 로고
    • The language of biosimilars: clarification, definitions, and regulatory aspects
    • PID: 28258517
    • Declerck P, Danesi R, Petersel D, Jacobs I. The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs. 2017;77:671–7. doi:10.1007/s40265-017-0717-1.
    • (2017) Drugs , vol.77 , pp. 671-677
    • Declerck, P.1    Danesi, R.2    Petersel, D.3    Jacobs, I.4


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