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Volumn 46, Issue , 2016, Pages 73-79

A clinician's guide to biosimilars in oncology

Author keywords

Biological product; Biosimilar; Cancer; Oncology

Indexed keywords

BEVACIZUMAB; RITUXIMAB; TRASTUZUMAB; ANTINEOPLASTIC AGENT; BIOSIMILAR AGENT;

EID: 84966269149     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/j.ctrv.2016.04.003     Document Type: Review
Times cited : (75)

References (54)
  • 1
    • 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
    • Baer I.W.H., 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. Pharm (Basel) 2014, 7:530-544. 10.3390/ph7050530.
    • (2014) Pharm (Basel) , vol.7 , pp. 530-544
    • Baer, I.W.H.1    Maini, A.2    Jacobs, I.3
  • 2
    • 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
    • Lammers P., Criscitiello C., Curigliano G., et al. 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. Pharm (Basel) 2014, 7:943-953. 10.3390/ph7090943.
    • (2014) Pharm (Basel) , vol.7 , pp. 943-953
    • Lammers, P.1    Criscitiello, C.2    Curigliano, G.3
  • 3
    • 79952744875 scopus 로고    scopus 로고
    • Worldwide experience with biosimilar development
    • McCamish M., Woollett G. Worldwide experience with biosimilar development. MAbs 2011, 3:209-217. .
    • (2011) MAbs , vol.3 , pp. 209-217
    • McCamish, M.1    Woollett, G.2
  • 4
    • 84857905655 scopus 로고    scopus 로고
    • The economic pressures for biosimilar drug use in cancer medicine
    • Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol 2012, 7(suppl 1):S57-S67. 10.1007/s11523-011-0196-3.
    • (2012) Target Oncol , vol.7 , pp. S57-S67
    • Cornes, P.1
  • 5
    • 84966283006 scopus 로고    scopus 로고
    • EMA, London, (last update, Oct 23, 2014),
    • European Medicines Agency Guideline on similar biological medicinal products 2014, EMA, London, (last update, Oct 23, 2014), [accessed 23.06.2015].
    • (2014) Guideline on similar biological medicinal products
  • 6
    • 84946092617 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD, (last update, Apr 2015),
    • US Food and Drug Administration Scientific considerations in demonstrating biosimilarity to a reference product. Gudiance for industry 2015, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD, (last update, Apr 2015), [accessed 1.05. 2015].
    • (2015) Scientific considerations in demonstrating biosimilarity to a reference product. Gudiance for industry
  • 8
    • 80053539103 scopus 로고    scopus 로고
    • Adjuvant trastuzumab in HER2-positive breast cancer
    • Slamon D., Eiermann W., Robert N., et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011, 365:1273-1283. 10.1056/NEJMoa0910383.
    • (2011) N Engl J Med , vol.365 , pp. 1273-1283
    • Slamon, D.1    Eiermann, W.2    Robert, N.3
  • 9
    • 84937000576 scopus 로고    scopus 로고
    • US Food and Drug Administration,
    • US Food and Drug Administration FDA approves first biosimilar product Zarxio 2015, US Food and Drug Administration, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm [accessed 18.11.2015].
    • (2015) FDA approves first biosimilar product Zarxio
  • 12
    • 85008254473 scopus 로고    scopus 로고
    • Recommendations for the regulation of biosimilars and their implementation in Latin America
    • Álvarez A.A., Mysler E., Ruiz de Castilla E.M., et al. Recommendations for the regulation of biosimilars and their implementation in Latin America. GaBI J 2014, 3:143-148. 10.5639/gabij.2014.0303.032.
    • (2014) GaBI J , vol.3 , pp. 143-148
    • Álvarez, A.A.1    Mysler, E.2    Ruiz de Castilla, E.M.3
  • 13
    • 84876470598 scopus 로고    scopus 로고
    • Biosimilars require scientifically reliable comparative clinical data
    • Azevedo V.F. Biosimilars require scientifically reliable comparative clinical data. Rev Bras Reumatol 2013, 53:129-131. 10.1590/S0482-50042013000100013.
    • (2013) Rev Bras Reumatol , vol.53 , pp. 129-131
    • Azevedo, V.F.1
  • 15
    • 20544460650 scopus 로고    scopus 로고
    • Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer
    • Buzdar A.U., Ibrahim N.K., Francis D., et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 2005, 23:3676-3685. 10.1200/JCO.2005.07.032.
    • (2005) J Clin Oncol , vol.23 , pp. 3676-3685
    • Buzdar, A.U.1    Ibrahim, N.K.2    Francis, D.3
  • 16
    • 33846297680 scopus 로고    scopus 로고
    • Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen
    • Buzdar A.U., Valero V., Ibrahim N.K., et al. Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen. Clin Cancer Res 2007, 13:228-233. 10.1158/1078-0432.CCR-06-1345.
    • (2007) Clin Cancer Res , vol.13 , pp. 228-233
    • Buzdar, A.U.1    Valero, V.2    Ibrahim, N.K.3
  • 17
    • 84878926256 scopus 로고    scopus 로고
    • HER2-targeted therapy in breast cancer: a systematic review of neoadjuvant trials
    • Dent S., Oyan B., Honig A., et al. HER2-targeted therapy in breast cancer: a systematic review of neoadjuvant trials. Cancer Treat Rev 2013, 39:622-631. 10.1016/j.ctrv.2013.01.002.
    • (2013) Cancer Treat Rev , vol.39 , pp. 622-631
    • Dent, S.1    Oyan, B.2    Honig, A.3
  • 18
    • 33846477245 scopus 로고    scopus 로고
    • Randomized phase II trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with HER-2 positive advanced breast cancer
    • Gasparini G., Gion M., Mariani L., et al. Randomized phase II trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with HER-2 positive advanced breast cancer. Breast Cancer Res Treat 2007, 101:355-365. 10.1007/s10549-006-9306-9.
    • (2007) Breast Cancer Res Treat , vol.101 , pp. 355-365
    • Gasparini, G.1    Gion, M.2    Mariani, L.3
  • 19
    • 75149145066 scopus 로고    scopus 로고
    • Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort
    • Gianni L., Eiermann W., Semiglazov V., et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010, 375:377-384. 10.1016/S0140-6736(09)61964-4.
    • (2010) Lancet , vol.375 , pp. 377-384
    • Gianni, L.1    Eiermann, W.2    Semiglazov, V.3
  • 20
    • 22344446208 scopus 로고    scopus 로고
    • Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group
    • Marty M., Cognetti F., Maraninchi D., et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 2005, 23:4265-4274. 10.1200/JCO.2005.04.173.
    • (2005) J Clin Oncol , vol.23 , pp. 4265-4274
    • Marty, M.1    Cognetti, F.2    Maraninchi, D.3
  • 21
    • 43249115659 scopus 로고    scopus 로고
    • Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840
    • Seidman A.D., Berry D., Cirrincione C., et al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 2008, 26:1642-1649. 10.1200/JCO.2007.11.6699.
    • (2008) J Clin Oncol , vol.26 , pp. 1642-1649
    • Seidman, A.D.1    Berry, D.2    Cirrincione, C.3
  • 22
    • 0035873815 scopus 로고    scopus 로고
    • Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification
    • Seidman A.D., Fornier M.N., Esteva F.J. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001, 19:2587-2595. .
    • (2001) J Clin Oncol , vol.19 , pp. 2587-2595
    • Seidman, A.D.1    Fornier, M.N.2    Esteva, F.J.3
  • 23
    • 0035869407 scopus 로고    scopus 로고
    • Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
    • Slamon D.J., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Eng J Med 2001, 344:783-792. 10.1056/NEJM200103153441101.
    • (2001) N Eng J Med , vol.344 , pp. 783-792
    • Slamon, D.J.1    Leyland-Jones, B.2    Shak, S.3
  • 24
    • 42249083269 scopus 로고    scopus 로고
    • Weekly paclitaxel in the adjuvant treatment of breast cancer
    • Sparano J.A., Wang M., Martino S., et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Eng J Med 2008, 358:1663-1671. 10.1056/NEJMoa0707056.
    • (2008) N Eng J Med , vol.358 , pp. 1663-1671
    • Sparano, J.A.1    Wang, M.2    Martino, S.3
  • 25
    • 84921058776 scopus 로고    scopus 로고
    • Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation
    • Jackisch C., Scappaticci F.A., Heinzmann D., et al. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation. Future Oncol 2015, 11:61-71. 10.2217/fon.14.187.
    • (2015) Future Oncol , vol.11 , pp. 61-71
    • Jackisch, C.1    Scappaticci, F.A.2    Heinzmann, D.3
  • 26
    • 84897377081 scopus 로고    scopus 로고
    • Biosimilars: in support of extrapolation of indications
    • Ebbers H.C. Biosimilars: in support of extrapolation of indications. J Crohns Colitis 2014, 8:431-435. 10.1016/j.crohns.2014.02.007.
    • (2014) J Crohns Colitis , vol.8 , pp. 431-435
    • Ebbers, H.C.1
  • 27
    • 84911401436 scopus 로고    scopus 로고
    • Biosimilars: the science of extrapolation
    • Weise M., Kurki P., Wolff-Holz E., et al. Biosimilars: the science of extrapolation. Blood 2014, 124:3191-3196. 10.1182/blood-2014-06-583617.
    • (2014) Blood , vol.124 , pp. 3191-3196
    • Weise, M.1    Kurki, P.2    Wolff-Holz, E.3
  • 28
    • 26844536978 scopus 로고    scopus 로고
    • Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
    • Romond E.H., Perez E.A., Bryant J., et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Eng J Med 2005, 353:1673-1684. 10.1056/NEJMoa052122.
    • (2005) N Eng J Med , vol.353 , pp. 1673-1684
    • Romond, E.H.1    Perez, E.A.2    Bryant, J.3
  • 29
    • 4644351840 scopus 로고    scopus 로고
    • Pure red-cell aplasia and epoetin therapy
    • Bennett C.L., Luminari S., Nissenson A.R., et al. Pure red-cell aplasia and epoetin therapy. N Eng J Med 2004, 351:1403-1408. 10.1056/NEJMoa040528.
    • (2004) N Eng J Med , vol.351 , pp. 1403-1408
    • Bennett, C.L.1    Luminari, S.2    Nissenson, A.R.3
  • 31
    • 84871492817 scopus 로고    scopus 로고
    • Biosimilars: what clinicians should know
    • Weise M., Bielsky M.C., De Smet K., et al. Biosimilars: what clinicians should know. Blood 2012, 120:5111-5117. 10.1182/blood-2012-04-425744.
    • (2012) Blood , vol.120 , pp. 5111-5117
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 32
    • 84959189652 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD, (last update, Apr 2015), <
    • US Food and Drug Administration Biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Gudiance for industry 2015, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Silver Spring, MD, (last update, Apr 2015), [accessed 01.05.2015].
    • (2015) Biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Gudiance for industry
  • 33
    • 84924722447 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients
    • Stenina M.B., Ignatova E., Frolova M.A., et al. Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients. J Clin Oncol 2014, 32(15 suppl):e11576. (Abstr) .
    • (2014) J Clin Oncol , vol.32 , Issue.15 , pp. e11576
    • Stenina, M.B.1    Ignatova, E.2    Frolova, M.A.3
  • 34
    • 84930740273 scopus 로고    scopus 로고
    • Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin®)
    • Hurst S., Ryan A.M., Ng C.K., et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin®). BioDrugs 2014, 28:451-459. 10.1007/s40259-014-0103-4.
    • (2014) BioDrugs , vol.28 , pp. 451-459
    • Hurst, S.1    Ryan, A.M.2    Ng, C.K.3
  • 35
    • 84919337080 scopus 로고    scopus 로고
    • A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01)
    • Yin D., Barker K.B., Li R., et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol 2014, 78:1281-1290. 10.1111/bcp.12464.
    • (2014) Br J Clin Pharmacol , vol.78 , pp. 1281-1290
    • Yin, D.1    Barker, K.B.2    Li, R.3
  • 36
    • 84911972652 scopus 로고    scopus 로고
    • A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers
    • Wisman L.A., De Cock E.P., Reijers J.A., et al. A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Invest 2014, 34:887-894. 10.1007/s40261-014-0247-5.
    • (2014) Clin Drug Invest , vol.34 , pp. 887-894
    • Wisman, L.A.1    De Cock, E.P.2    Reijers, J.A.3
  • 37
    • 84966367326 scopus 로고    scopus 로고
    • Phase I/IIB clinical trial comparing PK and safety of trastuzumab and its biosimilar candidate CT-P6
    • Im Y.-H., Krasnozhon D., Bondarenko I., et al. Phase I/IIB clinical trial comparing PK and safety of trastuzumab and its biosimilar candidate CT-P6. Breast 2013, 22(suppl):S108. .
    • (2013) Breast , vol.22 , pp. S108
    • Im, Y.-H.1    Krasnozhon, D.2    Bondarenko, I.3
  • 38
    • 84923881096 scopus 로고    scopus 로고
    • Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment
    • Im Y.-H., Odarchenko P., Grecea D. Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment. J Clin Oncol 2013, 31. Abstr 629. .
    • (2013) J Clin Oncol , vol.31
    • Im, Y.-H.1    Odarchenko, P.2    Grecea, D.3
  • 39
    • 84883879484 scopus 로고    scopus 로고
    • Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab
    • Visser J., Feuerstein I., Stangler T., et al. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs 2013, 27:495-507. 10.1007/s40259-013-0036-3.
    • (2013) BioDrugs , vol.27 , pp. 495-507
    • Visser, J.1    Feuerstein, I.2    Stangler, T.3
  • 40
    • 84900481066 scopus 로고    scopus 로고
    • Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013
    • da Silva A., Kronthaler U., Koppenburg V., et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma 2014, 55:1609-1617. 10.3109/10428194.2013.843090.
    • (2014) Leuk Lymphoma , vol.55 , pp. 1609-1617
    • da Silva, A.1    Kronthaler, U.2    Koppenburg, V.3
  • 41
    • 84924709889 scopus 로고    scopus 로고
    • Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma
    • Poddubnaya I., Babicheva L., Kaplanov K., et al. Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma. J Clin Oncol 2014, 32(15 suppl):e19545. (Abstr) .
    • (2014) J Clin Oncol , vol.32 , Issue.15 , pp. e19545
    • Poddubnaya, I.1    Babicheva, L.2    Kaplanov, K.3
  • 42
    • 84966304215 scopus 로고    scopus 로고
    • Key results of international randomized open-label clinical study of BCD-020 (rituximab biosimilar candidate) in patients with B-Cell non-hodgkin's lymphoma
    • Kaplanov K., Zaritskiy A., Alexeev S., et al. Key results of international randomized open-label clinical study of BCD-020 (rituximab biosimilar candidate) in patients with B-Cell non-hodgkin's lymphoma. Blood 2014, 124. (Abstr), .
    • (2014) Blood , vol.124
    • Kaplanov, K.1    Zaritskiy, A.2    Alexeev, S.3
  • 43
    • 84907525369 scopus 로고    scopus 로고
    • Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera(R))
    • Ryan A.M., Sokolowski S.A., Ng C.K., et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera(R)). Toxicol Pathol 2014, 42:1069-1081. 10.1177/0192623313520351.
    • (2014) Toxicol Pathol , vol.42 , pp. 1069-1081
    • Ryan, A.M.1    Sokolowski, S.A.2    Ng, C.K.3
  • 44
    • 84924685865 scopus 로고    scopus 로고
    • A phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis
    • S1
    • Becker J.-CP., Yin D.H., Melia L.A., et al. A phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis. Arthritis Rheum 2014, 66(S660). S1 (Abstr 1502), .
    • (2014) Arthritis Rheum , vol.66
    • Becker, J.-C.P.1    Yin, D.H.2    Melia, L.A.3
  • 45
    • 84924749432 scopus 로고    scopus 로고
    • A randomized, controlled, multicenter, 2-arm, parallel-group, double-blind study to demonstrate the equivalence of CT-P10 to innovator rituximab with respect to pharmacokinetic profile in patients with rheumatoid arthritis
    • S736-S
    • Yoo D.-H., Park W., Jeka S., et al. A randomized, controlled, multicenter, 2-arm, parallel-group, double-blind study to demonstrate the equivalence of CT-P10 to innovator rituximab with respect to pharmacokinetic profile in patients with rheumatoid arthritis. Arthritis Rheum 2013, 65(suppl). S736-S (Abstr 1736). 10.1002/art.2013.65.issue-s10.
    • (2013) Arthritis Rheum , vol.65
    • Yoo, D.-H.1    Park, W.2    Jeka, S.3
  • 46
    • 84966367351 scopus 로고    scopus 로고
    • Impact of anti-drug antibody on efficacy and safety over week 24 in both CT-P10 and innovator rituximab treatment groups
    • Yoo D-H., Park W., Jeka S. Impact of anti-drug antibody on efficacy and safety over week 24 in both CT-P10 and innovator rituximab treatment groups. Arthritis Rheum 2014, 66:S663-S664. (Abstr 1508). .
    • (2014) Arthritis Rheum , vol.66 , pp. S663-S664
    • Yoo, D.-H.1    Park, W.2    Jeka, S.3
  • 47
    • 84933066713 scopus 로고    scopus 로고
    • Development of RTXM83 (a potential rituximab biosimilar): in vitro and in vivo comparability with MabThera
    • Seigelchifer M., Corley E., Fresnillo G. Development of RTXM83 (a potential rituximab biosimilar): in vitro and in vivo comparability with MabThera. J Clin Oncol 2014, 32:e14020. (Abstr), .
    • (2014) J Clin Oncol , vol.32
    • Seigelchifer, M.1    Corley, E.2    Fresnillo, G.3
  • 48
    • 84966304248 scopus 로고    scopus 로고
    • Clinical pharmacokinetic (PK) and safety (immunogenicity) of rituximab biosimilar RTXM83 in combination with chemotherapy CHOP in patients with diffuse large B-cell lymphoma (DLBCL)
    • Florez A., Di Matteo T., Fresnillo G. Clinical pharmacokinetic (PK) and safety (immunogenicity) of rituximab biosimilar RTXM83 in combination with chemotherapy CHOP in patients with diffuse large B-cell lymphoma (DLBCL). Blood 2014, 124:5472. (Abstr), .
    • (2014) Blood , vol.124 , pp. 5472
    • Florez, A.1    Di Matteo, T.2    Fresnillo, G.3
  • 49
    • 84924722447 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients
    • Orlov S., Burdaeva O., Nechaeva M.P., et al. Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients. J Clin Oncol 2014, 32(15 suppl):e13500. (Abstr), .
    • (2014) J Clin Oncol , vol.32 , Issue.15 , pp. e13500
    • Orlov, S.1    Burdaeva, O.2    Nechaeva, M.P.3
  • 50
    • 84966377786 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., 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):8057. (Abstr), .
    • (2015) J Clin Oncol , vol.33 , pp. 8057
    • Filon, O.1    Orlov, S.2    Burdaeva, O.3
  • 53
    • 84966364350 scopus 로고    scopus 로고
    • A phase I study comparing PF-06439535 (a potential biosimilar) with bevacizumab
    • Knight B., Rassam D., Liao S., et al. A phase I study comparing PF-06439535 (a potential biosimilar) with bevacizumab. J Thorac Oncol 2015, 10(suppl 9):S548. (Abstr P2.01-079).
    • (2015) J Thorac Oncol , vol.10 , pp. S548
    • Knight, B.1    Rassam, D.2    Liao, S.3
  • 54
    • 84966265962 scopus 로고    scopus 로고
    • Nonclinical development of PF 06439535, a potential biosimilar to bevacizumab
    • (Abstr)
    • Rule K., Peraza M., Shiue M., et al. Nonclinical development of PF 06439535, a potential biosimilar to bevacizumab. J Thorac Oncol 2015, 10:S485. (Abstr).
    • (2015) J Thorac Oncol , vol.10 , pp. S485
    • Rule, K.1    Peraza, M.2    Shiue, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.