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Meta-Analysis
. 2024 Nov 28;11(11):CD013539.
doi: 10.1002/14651858.CD013539.pub2.

Biosimilar monoclonal antibodies for cancer treatment in adults

Tais F Galvao  1 , Annemeri Livinalli  1 , Luciane C Lopes  2 , Ivan R Zimmermann  3 , Marcus Tolentino Silva  3
Affiliations
Meta-Analysis

Biosimilar monoclonal antibodies for cancer treatment in adults

Tais F Galvao et al. Cochrane Database Syst Rev. .

Abstract

Background: Biosimilars are products containing an approved biological medicine. They are similar, but not identical, to an originator medicine. In cancer, biosimilars have been developed from the monoclonal antibodies, bevacizumab, rituximab, and trastuzumab. They have become available for the treatment of lung, colorectal, non-Hodkin's lymphoma, and breast cancers. As these biological products are not identical, synthesis of evidence of the clinical effects of biosimilars compared to their originators is needed to understand their comparative effectiveness and harms.

Objectives: To evaluate the benefits and harms of biosimilar monoclonal antibodies versus their originator drugs for adults with cancer.

Search methods: We searched bibliographic (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trials databases to February 2024.

Selection criteria: We included head-to-head randomised controlled trials conducted in adults with cancer treated with biosimilar or originator monoclonal antibodies.

Data collection and analysis: We followed standard Cochrane methodology. Primary outcomes were progression-free survival, duration of response, overall survival, breast cancer's pathological complete response, serious adverse events, and health-related quality of life. If survival estimates were adjusted or provided as rates, we did not combine them. We used Cochrane's RoB 1 tool to assess the risk of bias and GRADE to evaluate the certainty of evidence of critical and important outcomes according to the relevance determined by consumers.

Main results: We included 55 studies with 22,046 adults (23 of bevacizumab, 10,639 participants with colorectal or lung cancer; 17 of rituximab, 4412 participants with non-Hodgkin's lymphoma; and 15 of trastuzumab, 6995 participants with breast cancer). Studies were conducted in all continents, most were multicentre, and all were funded by the drug manufacturer. Participants' ages ranged from 47 (mean) to 62 (median) years and the proportion of women from 18% to 100%. Fifteen studies were conducted as non-inferiority and 40 as equivalence. The overall risk of bias was low; main biases were in the incomplete outcome data and selective reporting domains. Bevacizumab biosimilar versus bevacizumab originator in lung or colorectal cancer Progression-free survival is likely similar between bevacizumab biosimilar and the originator (per 1000: 380 in both groups at 12 months, hazard ratio (HR) 1.00, 95% confidence interval (CI) 0.91 to 1.09; 5 studies, 2660 participants; moderate-certainty evidence). There were no differences in lung or colorectal cancer subgroups. Bevacizumab biosimilar is likely similar to the originator in duration of response (per 1000: 219 participants who achieved response progressed with biosimilar versus 210 with originator at 12 months; HR 1.05, 95% CI 0.81 to 1.37; 1 study, 762 participants; moderate-certainty evidence) and overall survival (per 1000: 592 with biosimilar versus 610 with originator at 12 months; HR 1.06, 95% CI 0.94 to 1.19; 5 studies, 2783 participants; moderate-certainty evidence). There were no differences in cancer type subgroups. Bevacizumab biosimilar is likely similar to the originator in serious adverse events (per 1000: 303 with biosimilar versus 309 with originator; risk ratio (RR) 0.98, 95% CI 0.93 to 1.03; 23 studies, 10,619 participants; moderate-certainty evidence). Bevacizumab biosimilar may be similar to originator in health-related quality of life as scores were comparable in the one study that assessed this outcome in metastatic colorectal cancer (low-certainty evidence). This critical outcome was not assessed in other biosimilars comparisons. Bevacizumab biosimilar is likely similar to originator in objective response (per 1000: 481 with biosimilar versus 501 with originator; RR 0.96, 95% CI 0.93 to 1.00; 23 studies, 10,054 participants; moderate-certainty evidence) and mortality (per 1000: 287 with biosimilar versus 279 with originator; RR 1.03, 95% CI 0.97 to 1.09; 19 studies, 9231 participants; moderate-certainty evidence). There were no differences in lung or colorectal cancers. Rituximab biosimilar versus rituximab originator in non-Hodgkin's lymphoma Rituximab biosimilar is likely similar to originator in progression-free survival (7 studies, 2456 participants), duration of response (2 studies, 522 participants), and overall survival (7 studies, 2353 participants; data not pooled as survival estimates were adjusted for different factors or reported as rates) (all moderate-certainty evidence). Rituximab biosimilar is likely similar to originator in the risk of serious adverse events (per 1000: 210 with biosimilar versus 204 with originator; RR 1.03, 95% CI 0.94 to 1.14; 15 studies, 4197 participants; moderate-certainty evidence) and objective response (per 1000: 807 with biosimilar versus 799 with originator; RR 1.01, 95% CI 0.98 to 1.04; 16 studies, 3922 participants; moderate-certainty evidence). No study reported quality of life. Rituximab biosimilar is similar to originator in mortality (per 1000: 52 with biosimilar versus 53 with originator; RR 0.97, 95% CI 0.70 to 1.35; 8 studies, 2557 participants; high-certainty evidence). Trastuzumab biosimilar versus trastuzumab originator in breast cancer Trastuzumab biosimilar is likely similar to originator in progression-free survival (4 studies, 2221 participants), duration of response (3 studies, 1488 participants), and overall survival (6 studies, 2221 participants), which were not pooled due to adjustment for different factors or provided as rates. No study reported quality of life. Trastuzumab biosimilar may be similar to originator in pathological complete response (per 1000: 459 with biosimilar versus 433 with originator; RR 1.06, 95% CI 0.95 to 1.17; 7 studies, 3403 participants; low-certainty evidence), is likely similar in serious adverse events (per 1000: 129 in both groups; RR 1.00, 95% CI 0.85 to 1.17; 13 studies, 6183 participants; moderate-certainty evidence), and slightly increases objective response (per 1000: 801 with biosimilar versus 777 with originator; RR 1.03, 95% CI 1.01 to 1.05; 13 studies, 5509 participants; moderate-certainty evidence).

Authors' conclusions: Treatment with bevacizumab, rituximab, and trastuzumab biosimilars are likely similar to their originator drugs in terms of their impact on progression-free survival, duration of response, overall survival, serious adverse events, objective response, and mortality. Limited evidence showed similarity in pathological complete response for trastuzumab and quality of life for bevacizumab compared with originators, which was not assessed in the other comparisons. The overall certainty of evidence was moderate and imprecision was the main reason for downgrading our certainty in the findings.

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Conflict of interest statement

TFG: none.

AL: received fees from Aché (2018–2023), Amgen (2018–2020), Daiichi Sankyo Company (2021), Farmarin (2022), Laboratorios Pfizer (2022), Servier do Brasil (2020), Servier Laboratoires (2022–2023), Teva Pharmaceutical Industries (2020, 2021); Grant/contract from Pan American Health Organization (2022–2023).

LCL: none.

IRZ: none.

MTS: none.

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    1. Ohe Y, Bondarenko I, Andric Z, Ostapenko Y, Ciuleanu T, Moiseenko F, et al. Abstract CT551: randomized phase III study comparing the efficacy and safety of CT-P16, a new biosimilar, to reference bevacizumab (Avastin®) in patients with metastatic or recurrent non-small cell lung cancer (NSCLC). Cancer Research 2022;Suppl 12:CT551. [DOI: 10.1158/1538-7445.AM2022-CT551] - DOI
    1. Verschraegen C, Andric AG, Ciuleanu T-E, Moiseenko FV, Makharadze T, Shevnia S, et al. 1-year follow-up of a phase III study to compare efficacy and safety of a bevacizumab biosimilar, CT-P16, and reference bevacizumab as first-line treatment for metastatic or recurrent non-squamous non-small cell lung cancer. Annals of Oncology 2022;33(S7):S1024. [DOI: 10.1016/j.annonc.2022.07.1153] - DOI
    1. Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, et al. Candidate bevacizumab biosimilar CT-P16 versus European Union reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer: a randomized controlled trial. BioDrugs 2022;36:749-60. [DOI: 10.1007/s40259-022-00552-8] - DOI - PMC - PubMed
b‐Wang 2021 {published data only}
    1. Wang J, Wang R, Dong X, Chen Q, Yu Y, Yang S, et al. 1339P Efficacy and safety of MIL60, a bevacizumab biosimilar, in combination with paclitaxel/carboplatin in patients with advanced or recurrent non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter phase III study. Annals of Oncology 2021;32:S1023. [DOI: 10.1016/j.annonc.2021.08.1940] - DOI
b‐Yang 2019 {published data only}
    1. Yang Y, Wu B, Huang L, Shi M, Liu Y, Zhao Y, et al. Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer. Translational Lung Cancer Research 2019;8(6):989-99. [DOI: 10.21037/tlcr.2019.12.23] - DOI - PMC - PubMed
    1. Zhang L, Wu B, Huang L, Shi M, Liu Y, Zhao Y, et al. Efficacy and safety of IBI305 compared with bevacizumab in advanced non-squamous NSCLC patients as first-line treatment in a randomized, double-blind, phase III study. Journal of Clinical Oncology 2019;37(Suppl 15):9095. [DOI: 10.1200/JCO.2019.37.15_suppl.9095] - DOI
b‐Zhou 2020 {published data only}
    1. Lu S, Qin S, Zhow Z, Chen J, Gu K, Sun P, et al. Bevacizumab biosimilar candidate TAB008 compared to Avastin® in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study. Journal of Cancer Research and Clinical Oncology 2023;149(9):5907-14. [DOI: 10.1007/s00432-022-04563-4] - DOI - PMC - PubMed
    1. NCT05427305. TAB008 compared to Avastin® in patients with EGFR wild-type non-squamous non-small cell lung cancer. clinicaltrials.gov/ct2/show/NCT05427305 (first received 22 June 2022).
    1. Zhou Z, Lu S, Qin S, Chen J, Gu K, Sun P, et al. 388P biosimilar TAB008 compared with bevacizumab in advanced non-squamous, non-small cell, EGFR wildtype lung cancer patients. Annals of Oncology 2020;31(Suppl 6):S1393-4. [DOI: 10.1016/j.annonc.2020.10.382] - DOI
r‐Advani 2018b {published data only}
    1. Advani S, Biswas G, Sinha S, Rayala N, Chary S, Thakur P, et al. A randomized, multiple-dose, multicenter, comparative parallel study to evaluate the safety and efficacy of intravenous infusion of rituximab (Hetero) and reference medicinal product (rituximab, Roche) in Indian patients of non-Hodgkin's lymphoma (HERILY). Indian Journal of Medical and Paediatric Oncology 2018;39(3):316-20. [DOI: 10.4103/ijmpo.ijmpo_25_17] - DOI
    1. Advani S, Sinha S, Thakur P, Naidu N, Chary S, Biswas G, et al. Efficacy, safety and immunogenecity study of intravenous infusion of rituximab (Hetero) and reference medicinal product (rituximab, Roche) in Indian patients of follicular lymphoma preliminary report (HERILY). Journal of Association of Physicians of India 2017;65(October):58-62. - PubMed
r‐Buske 2021 {published data only}
    1. Buske C, Kim W, Kwak L, Coiffier B, Jurczak W, Sancho JM, et al. A double-blind, randomized phase 3 study to compare efficacy and safety of CT-P10 to rituximab in combination with CVP in patients with advanced-stage follicular lymphoma. Hematological Oncology 2017;35:218-20. [DOI: 10.1002/hon.2438_83] - DOI
    1. Buske C, Kwak LW, Jurczak W, Sancho JM, Zhavrid E, Kim JS, et al. Long-term efficacy and safety results of CT-P10 and reference rituximab in patients with newly diagnosed advanced stage follicular lymphoma: phase III updated study results with median follow-up of 40 months. Blood 2019;134(Suppl 1):1528. [DOI: 10.1182/blood-2019-126379] - DOI
    1. Coiffier B, Sancho J-M, Jurczak W, Kim JS, Nagarkar RV, Zhavrid E, et al. Pharmacokinetic and safety of CT-P10, a biosimilar candidate to the rituximab reference product, in patients with newly diagnosed advanced stage follicular lymphoma (AFL). Blood 2016;128(22):1807. [DOI: 10.1182/blood.V128.22.1807.1807] - DOI
    1. Kim W-S, Buske C, Kwak LW, Ogura M, Coiffier B, Lee SJ, et al. Similar efficacy and safety of CT-P10 and reference rituximab in patients with advanced stage follicular lymphoma: updated phase III study results. Blood 2018;132(Suppl 1):1616. [DOI: 10.1182/blood-2018-99-112716] - DOI
    1. Kim W-S, Jurczak W, Sancho J-M, Javrid E, Kim JS, Angel J, et al. Double-blind, randomized phase 3 study to compare efficacy and safety of the biosimilar CT-P10 to rituximab combined with CVP therapy in patients with previously untreated advanced-stage follicular lymphoma. Journal of Clinical Oncology 2017;35(Suppl 15):7532. [DOI: 10.1200/JCO.2017.35.15_suppl.7532] - DOI
r‐Candelaria 2019 {published data only}
    1. Candelaria M, Gonzalez D, Fernández GF, Paravisini A, Del Campo GA, Pérez L, et al. Comparative assessment of pharmacokinetics, and pharmacodynamics between RTXM83™, a rituximab biosimilar, and rituximab in diffuse large B-cell lymphoma patients: a population PK model approach. Cancer Chemotherapy and Pharmacology 2018;81(3):515-27. [DOI: 10.1007/s00280-018-3524-9] - DOI - PubMed
    1. Candelaria M, Gonzalez DE, Beniwal SK, Dasappa L, Bar DO, Delamain MT, et al. A randomized, double-blind, phase III study comparing proposed biosimilar rituximab (RTXM83) versus reference rituximab, both in combination with CHOP, in the first line treatment of patients with diffuse large B-cell lymphoma (DLBCL). Blood 2017;130(Suppl 1):1556. [DOI: 10.1182/blood.V130.Suppl_1.1556.1556] - DOI
    1. Candelaria M, González DE, Delamain MT, Bär DO, Beniwal SK, Dasappa L, et al. Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study. Leukemia & Lymphoma 2019;60(14):3375-85. [DOI: 10.1080/10428194.2019.1633632] - DOI - PubMed
    1. NCT02268045. Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with non Hodgkin's lymphoma. clinicaltrials.gov/ct2/show/NCT02268045 (first received 20 October 2014).
r‐Jiang 2020 {published data only}
    1. Jiang B, Ke X, Zhang Q, Xu W, Su H, Huang J, et al. Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study. Scientific Reports 2020;10(1):11676. [DOI: 10.1038/s41598-020-68360-0] - DOI - PMC - PubMed
    1. NCT02945215. A study to assess the pharmacokinetics and safety of recombinant human murine chimeric anti CD20 monoclonal antibody injection (IBI301) compared to rituximab injection in CD20 positive B cell lymphoma patients. clinicaltrials.gov/ct2/show/NCT02945215 (first received 26 October 2016).
r‐Jurczak 2017 {published data only}
    1. EUCTR2010-019522-13. A randomized, controlled, double-blind phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus MabThera® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-01952... (first received 7 October 2011).
    1. European Medicines Agency. Assessment report: rixathon. https://www.ema.europa.eu/en/documents/assessment-report/rixathon-epar-p... (accessed prior to 3 October 2024).
    1. European Medicines Agency. Assessment report: riximyo. https://www.ema.europa.eu/en/documents/assessment-report/riximyo-epar-pu... (accessed prior to 3 October 2024).
    1. Jurczak W, Ilidia M, Govindbabu KS, Eduardo M, Ascuncion EM, Giri P, et al. A phase III efficacy and safety study of the proposed rituximab biosimilar GP2013 versus rituximab in patients with previously untreated advanced follicular lymphoma. Blood 2016;128(22):1809. [DOI: 10.1182/blood.V128.22.1809.1809] - DOI
    1. Jurczak W, Moreira I, Govindbabu KS, Munhoz E, Echeveste M-A, Giri P, et al. Equivalent efficacy of a biosimilar rituximab and reference rituximab in previously untreated advanced follicular lymphoma: extended results of ASSIST-FL, a confirmatory phase III study. Annals of Oncology 2017;28:v355. [DOI: 10.1093/annonc/mdx373] - DOI - PubMed
r‐Kim 2012 {published data only}
    1. Archigen Biotech Limited. Protocol number AGB 002. A randomized, double-blind, multi-center, multinational trial to evaluate the efficacy, safety, and immunogenicity of SAIT101 versus rituximab as a first-line immunotherapy treatment in patients with low tumor burden follicular lymphoma. Archigen Biotech Limited 2017 (Amendment 03):116.
    1. EudraCT 2016-001966-27. A randomized, double-blind, multi-center, multi-national trial to evaluate the efficacy, safety, and immunogenicity of SAIT101 versus rituximab as a first-line immunotherapy treatment in patients with low tumor burden follicular lymphoma. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-00196... (first received 7 September 2016).
    1. Kim SJ, Kim WS, Kang HJ, Kim JS, Choi CW, Lee SI, et al. Safety, pharmacokinetic/pharmacodynamic profiles and efficacy of SAIT101, a biosimilar of rituximab in patients with diffuse large B-cell lymphoma. Haematologica 2012;12(Suppl 1):317-8.
    1. NCT02809053. A randomized, double-blind, multi-center, multi-national trial to evaluate the efficacy, safety, and immunogenicity of SAIT101 versus rituximab as a first-line immunotherapy treatment in patients with low tumor burden follicular lymphoma. clinicaltrials.gov/show/nct02809053 (first received 22 June 2016).
r‐NCT02617485 {published data only}
    1. Clinical study protocol. Randomized, parallel-group, double-blind, comparative bioequivalence trial of MABIONCD20 (MABION SA) compared to MabThera (rituximab by Hoffman-la Roche) in patients with diffuse large B-cell lymphoma. classic.clinicaltrials.gov/ProvidedDocs/85/NCT02617485/Prot_000.pdf (first received 21 September 2016).
    1. EUCTR 2013-005506-56. Randomized, parallel-group, double-blind, comparative bioequivalence trial of MabionCD20 (Mabion S.A) compared to MabThera (rituximab by Hoffman-La Roche) in patients with diffuse large B-cell Lymphoma. clinicaltrialsregister.eu/ctr-search/search?query=2013-005506-56 (first received 4 January 2018).
    1. NCT02617485. MabionCD20® compared to MabThera® in lymphoma patients (MADILYM). clinicaltrials.gov/ct2/show/study/NCT02617485 (first received 1 December 2015).
r‐NCT03976102 {published data only}
    1. Clinical study protocol. A randomised, double-blind, parallel-group, phase III study to compare the efficacy, safety, and immunogenicity of proposed rituximab biosimilar (DRL_RI) with MabThera® in subjects with previously untreated, stage II-IV, cluster of differentiation (CD)20-positive, low tumour burden follicular lymphoma (protocol number: ri-01-006). cdn.clinicaltrials.gov/large-docs/02/NCT03976102/Prot_000.pdf (first received 27 October 2021).
    1. EudraCT number 2018-004223-36. A randomised, double-blind, parallel-group, phase III study to compare the efficacy, safety, and immunogenicity of proposed rituximab biosimilar (DRL_RI) with MabThera® in subjects with previously untreated (CD)20-positive ltb follicular lymphoma. clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-00... (first received 23 September 2019).
    1. NCT03976102. A double-blind, parallel-group, phase III study to compare the efficacy, safety, and immunogenicity of proposed rituximab biosimilar (DRL_RI) with MabThera® in subjects with previously untreated (CD)20-positive LTB follicular lymphoma. clinicaltrials.gov/ct2/show/NCT03976102 (first received 5 June 2019).
r‐Niederwieser 2020 {published data only}
    1. Amgen Inc. Clinical study report 20130109: ABP 798. https://www.amgentrials.com/ (accessed prior to 7 October 2024).
    1. Center for Drug Evaluation and Research. Multi-discipline review: riabni. https://www.accessdata.fda.gov/drugsatfda_docs/nda.
    1. Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, et al. Efficacy and safety of ABP 798 compared with rituximab: results from the comparative clinical study in patients with non-Hodgkin's lymphoma. In: European Hematology Association. EHA 25 Virtual. European Hematology Association, 2020.
    1. Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, et al. Efficacy and safety of ABP 798: results from the jasmine trial in patients with follicular lymphoma in comparison with rituximab reference product. Targeted Oncology 2020;15(5):599-611. [DOI: 10.1007/s11523-020-00748-4] - DOI - PMC - PubMed
    1. Niederwieser D, Hamm CM, Cobb P, Mo M, Forsyth C, Tucci A, et al. Efficacy and safety of ABP 798 compared with rituximab: results from the comparative clinical study in patients with non-Hodgkin's. Journal of Clinical Oncology 2020;38(Suppl 15):8044. [DOI: 10.1200/JCO.2020.38.15_suppl.8044] - DOI
r‐Ogura 2018 {published data only}
    1. European Medicines Agency. Assessment report: Truxima. https://ema.europa.eu/en/documents/assessment-report/truxima-epar-public... (accessed prior to 3 October 2024).
    1. Kwak LW, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, et al. Efficacy and safety of CT-P10 versus rituximab in untreated low-tumor-burden follicular lymphoma: final results of a randomized phase III study. Clinical Lymphoma, Myeloma & Leukemia 2022;22(2):89-97. [DOI: 10.1016/j.clml.2021.08.005] - DOI - PubMed
    1. NCT02260804. To compare efficacy and safety between CT-P10 and Rituxan in patients with low tumour burden follicular lymphoma. clinicaltrials.gov/ct2/show/NCT02260804 (first received 9 October 2014).
    1. Ogura M, Sancho JM, Cho S-G, Nakazawa H, Suzumiya J, Tumyan G, et al. Comparison of efficacy and safety of biosimilar CT-P10 to rituximab in patients with previously untreated low tumor burden follicular lymphoma (LTBFL): a randomized phase III study. Blood 2018;132(Suppl 1):1596. [DOI: 10.1182/blood-2018-99-110334] - DOI
    1. Ogura M, Sancho JM, Cho Seok-Goo, Nakazawa H, Suzumiya J, Tumyan G, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematology 2018;5(11):e543-53. [DOI: 10.1016/S2352-3026(18)30157-1] - DOI - PubMed
r‐Patel 2023 {published data only}
    1. CTRI/2018/07/014885. Randomized, assessor-blind, multicentre, parallel group, two arms, clinical study to assess the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety of rituximab (test product, Zydus) in comparison with rituximab (reference product, Roche/Genentech) in patients with diffuse large B cell lymphoma (DLBCL). ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjY4MTM=&Enc=&us... (first received 16 July 2018).
    1. Patel A, Bhatt N, Prakash SS, Biswas G, Nagarkar R, Roy B, et al. Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India. Cancer Chemotherapy and Pharmacology 2023;91:457-68. [DOI: 10.1007/s00280-023-04530-x] - DOI - PMC - PubMed
r‐Poddubnaya 2020 {published data only}
    1. Alexeev S, Zaritskey A, Volodicheva E, Loginov A, Orlova R, Dvornichenko V, et al. Clinical comparability of BCD-020 to innovator rituximab in patients with indolent non-Hodgkin's lymphoma. Haematologica 2014;99(Suppl 1):144-5.
    1. Kaplanov K, Zaritskiy A, Alexeev S, Volodicheva E, Loginov A, Orlova R, 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(21):5467. [DOI: 10.1182/blood.V124.21.5467.5467] - DOI
    1. NCT01701232. Safety and efficacy study of BCD-020 in therapy of indolent non-Hodgkin's lymphoma. clinicaltrials.gov/ct2/show/NCT01701232 (first received 5 October 2012).
    1. Poddubnaya I, Babicheva L, Kaplanov K, Zaritskey A, Volodicheva E, Alexeev S, et al. Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma. Journal of Clinical Oncology 2014;32(Suppl 15):e19545. [DOI: 10.1200/jco.2014.32.15_suppl.e19545] - DOI
    1. Poddubnaya IV, Alekseev SM, Kaplanov KD, Lukavetskyy LM, Rekhtman GB, Dolai TK, et al. Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: an international multicenter randomized trial. Hematological Oncology 2020;38(1):67-73. [DOI: 10.1002/hon.2693] - DOI - PubMed
r‐Sharman 2020 {published data only}
    1. European Medicines Agency. Assessment report: ruxience. https://ema.europa.eu/en/documents/assessment-report/ruxience-epar-publi... (accessed prior to 3 October 2024).
    1. NCT02213263. A study of PF-05280586 (rituximab-Pfizer) or MabThera® (rituximab-EU) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (reflections b328-06). clinicaltrials.gov/ct2/show/NCT02213263 (first received 11 August 2014).
    1. Sharman J, Liberati AM, Santucci SR, Aurer I, Robbins J, Rosenberg JA, et al. A randomized, double-blind efficacy and safety study of PF-05280586 (a potential rituximab biosimilar) compared with rituximab reference product (MabThera®) in subjects with previously untreated CD20-positive, low tumor burden follicular lymphoma (LTB-FL). Blood 2018;132(Suppl 1):394. [DOI: 10.1182/blood-2018-99-111248] - DOI - PMC - PubMed
    1. Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, et al. A randomized, double-blind, efficacy and safety study of PF-05280586 (a rituximab biosimilar) compared with rituximab reference product (MabThera®) in subjects with previously untreated CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). BioDrugs 2020;34(2):171-81. [DOI: 10.1007/s40259-019-00398-7] - DOI - PMC - PubMed
r‐Shi 2020 {published data only}
    1. NCT02787239. Clinical study to compare the efficacy and safety of rituximab biosimilar HLX01 and rituximab in combination with CHOP, in previously untreated subjects with CD20+ DLBCL. clinicaltrials.gov/ct2/show/study/NCT02787239 (first received 1 June 2016).
    1. Qin Y, Song Y, Wang D, Bai O, Feng J, Sun X, et al. Long-term outcomes with HLX01(HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study. BMC Cancer 2024;24(124):1-10. [DOI: 10.1186/s12885-024-11876-9] - DOI - PMC - PubMed
    1. Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, et al. A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma. Journal of Hematology & Oncology 2020;13(1):38. [DOI: 10.1186/s13045-020-00871-9] - DOI - PMC - PubMed
    1. Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, et al. First China approved rituximab biosimilar HLX01: pharmacokinetics, safety and efficacy comparison to reference rituximab in the phase 3 diffuse large B-cell lymphoma study. Blood 2019;134(Suppl 1):2878. [DOI: 10.1182/blood-2019-130603] - DOI
    1. Shi Y, Zhang Q, Han X, Song Y, Qin Y, Hong X, et al. First China-manufactured proposed rituximab biosimilar met primary efficacy and safety endpoints in CD20-positive diffuse large B-cell lymphoma (generics). Annals of Oncology 2018;29:ix88. [DOI: 10.1093/annonc/mdy437.005] - DOI
r‐Song 2021 {published data only}
    1. Song Y, Zhou H, Zhang H, Liu W, Shuang Y, Zhou K, et al. Efficacy and safety of the biosimilar IBI301 plus standard CHOP (I-CHOP) in comparison with rituximab plus CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): a randomized, double-blind, parallel-group, phase 3 trial. Advances in Therapy 2021;38(4):1889-903. [DOI: 10.1007/s12325-020-01603-8] - DOI - PubMed
r‐Toogeh 2018 {published data only}
    1. Toogeh G, Faranoush M, Razavi SM, Jalaeikhoo H, Allahyari A, Ravanbod MR, et al. A double-blind, randomized comparison study between Zytux™ vs MabThera® in treatment of CLL with FCR regimen: non-inferiority clinical trial. International Journal of Hematology-Oncology and Stem Cell Research 2018;12(2):84-91. - PMC - PubMed
r‐Viswabandya 2019 {published and unpublished data}
    1. Shah S, Viswabandya A, Mukhopadhyay A, Nagarkar RV, Sachdeva BS, Lopez LL, et al. Comparative double-blind randomized trial of 2 rituximab products in patients with CD20+ diffuse large B-cell lymphoma (DLBCL). Journal of Clinical Oncology 2017;35(Suppl 15):7550. [DOI: 10.1200/JCO.2017.35.15_suppl.7550] - DOI
    1. Viswabandya A, Mukhopadhyay A, Shah S, Nagarkar RV, Batra SS, Lazaro LL, et al. Comparison of pharmacokinetics and pharmacodynamics of two anti-CD20 monoclonal antibodies (candidate biosimilar DRL-rituximab and innovator reference product rituximab (MabThera®)) in a randomised, multi-centre, double-blind, parallel group study of CHOP. Blood 2016;128(22):5391. [DOI: 10.1182/blood.V128.22.5391.5391] - DOI
    1. Viswabandya A, Shah S, Mukhopadhyay A, Nagarkar RV, Batra SS, Lopez-Lazaro L, et al. Randomized, double-blind, pharmacokinetic equivalence trial comparing DRL-rituximab with MabThera in patients with diffuse large B-cell lymphoma. Journal of Global Oncology 2019;2019(5):1-13. [DOI: 10.1200/JGO.19.00248] - DOI - PMC - PubMed
t‐Alexeev 2020 {published data only}
    1. Alexeev SM, Khorinko AV, Mukhametshina GZ, Shelepen KG, Burdaeva ON, Kulik SA, et al. Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab. BMC Cancer 2020;20(1):783. [DOI: 10.1186/s12885-020-07247-9] - DOI - PMC - PubMed
    1. NCT01764022. A safety and efficacy study of BCD-022 with paclitaxel compared to Herceptin with paclitaxel in HER2-positive metastatic breast cancer patients. clinicaltrials.gov/ct2/show/NCT01764022 (first received 7 January 2013).
t‐Apsangikar 2017b {published data only}
    1. Apsangikar P, Chaudhry S, Naik M, Deoghare S, Joseph J. A comparative phase III clinical study to evaluate efficacy and safety of TrastuRel™ (biosimilar trastuzumab) and innovator trastuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. Indian Journal of Cancer 2017;54(4):664. [DOI: 10.4103/ijc.IJC_449_17] - DOI - PubMed
t‐Esteva 2019 {published data only}
    1. Esteva FJ, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, et al. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemotherapy and Pharmacology 2019;84(4):839-47. [DOI: 10.1007/s00280-019-03920-4] - DOI - PMC - PubMed
    1. Esteva FJ, Chung HC, Royce ME, Lee SY, Lee SJ, Stebbing J. Abstract P5-20-14: cardiotoxicity in 1 year of treatment with reference trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early stage breast cancer (EBC) patients. Cancer Research 2018;78(Suppl 4):P5-20-14. [DOI: 10.1158/1538-7445.SABCS17-P5-20-14] - DOI
    1. Esteva FJ, Lee S, Yu S, Kim M, Kim N, Stebbing J. P6-17-03: 24 months results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC). Cancer Research 2019;79(Suppl 4):P6-17-03. [DOI: 10.1158/1538-7445.SABCS18-P6-17-03] - DOI
    1. European Medicines Agency. Assessment report of herzuma. https://ema.europa.eu/en/documents/assessment-report/herzuma-epar-public... (accessed prior to 3 October 2024).
    1. NCT02162667. Efficacy and safety evaluating study of CT-P6 in HER2 positive early breast cancer. clinicaltrials.gov/ct2/show/NCT02162667 (first received 13 June 2014).
t‐Im 2013 {published data only}
    1. Im Y, Krasnozhon D, Bondarenko I, Zvirbule Z, Jung K, Oliynychenko P, et al. Phae I/IIB clinical trial comparing PK and safety of trastuzumab and its biosimilar candidate CT-P6. Breast 2013;22(Suppl 1):S108.
    1. NCT01084863. Evaluate safety, efficacy and pharmacokinetics (compare). clinicaltrials.gov/ct2/show/NCT01084863 (first received 11 March 2010).
t‐Krivorotko 2021 {published and unpublished data}
    1. Clinical study protocol. A randomized, double-blind, parallel group, phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin® in subjects with HER2 positive early breast cancer. Tanvex Biologics Corp 30 November 2017;Protocol TX05-03 Amendment 1:80.
    1. Krivorotko P, Manikhas A, Moiseenko F, Poddubskaya E, Neciosup SP, Gopichand M, et al. 137P Trial comparing the safety, efficacy and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ early breast cancer. Annals of Oncology 2021;32:S419. [DOI: 10.1016/j.annonc.2021.08.418] - DOI
    1. NCT03556358. A randomized, double-blind, parallel-group, phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin® in subjects with HER2 positive early breast cancer. clinicaltrials.gov/ct2/show/NCT03556358 (first received 14 June 2018).
    1. NCT04109391. Extension study to provide adjuvant treatment following neoadjuvant treatment and surgical resection in protocol TX05-03. clinicaltrials.gov/ct2/show/NCT04109391 (first received 30 September 2019).
t‐Lammers 2018 {published data only}
    1. European Medicines Agency. Assessment report of Trazimera. https://www.ema.europa.eu/en/documents/assessment-report/trazimera-epar-... (accessed prior to 3 October 2024).
    1. Lammers PE, Dank M, Masetti R, Abbas R, Hilton F, Coiro J, et al. A randomized, double-blind study of PF-05280014 (a potential biosimilar) vs trastuzumab, both given with docetaxel (D) and carboplatin (C), as neoadjuvant treatment for operable human epidermal growth factor receptor 2-positive (HER2+) breast cancer. Annals of Oncology 2017;28(Suppl 5):v43. [DOI: 10.1093/annonc/mdx362.005] - DOI
    1. Lammers PE, Dank M, Masetti R, Abbas R, Hilton F, Coppola J, et al. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer. British Journal of Cancer 2018;119(3):266-73. [DOI: 10.1038/s41416-018-0147-1] - DOI - PMC - PubMed
    1. NCT02187744. A study of PF-05280014 or trastuzumab plus Taxotere and carboplatin In HER2 positive breast cancer in the neoadjuvant setting (REFLECTIONS B327-04). clinicaltrials.gov/ct2/show/NCT02187744 (first received 11 July 2014).
t‐Mohan 2023 {published data only}
    1. CTRI/2020/04/024456. A multicenter, double-blind, randomized, parallel-group, active-controlled, phase III study to evaluate the efficacy, safety, immunogenicity and pharmacokinetics of BP02 (trastuzumab) in comparison with Herceptin®-EU in patients with HERr2-positive metastatic breast cancer (MBC). ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Mzk3MDI=&Enc=&us... (first received 3 April 2020).
    1. Mohan K, Prajapati A, Kothari RK, Mondal S, R S, Nagarkar R, et al. Efficacy and safety of trastuzumab biosimilar in HER2+ metastatic breast cancer: a multicenter phase III study. Annals of Oncology 2023;34(Suppl 4):S1491. [DOI: 10.1016/j.annonc.2023.10.201] - DOI - PMC - PubMed
t‐Nodehi 2022 {published data only}
    1. NCT03425656. Comparing efficacy and safety of AryoGen pharmed biosimilar trastuzumab (AryoTrust) versus Herceptin® in breast cancer. clinicaltrials.gov/ct2/show/NCT03425656 (first received 7 February 2018).
    1. Nodehi RS, Kalantari B, Raafat J, Ansarinejad N, Moazed V, Mortazavizadeh SM, et al. A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed trastuzumab biosimilar) and Herceptin (trastuzumab reference product) in HER2-positive early-stage breast cancer patients. BMC Pharmacology and Toxicology 2022;23:57. [DOI: 10.1186/s40360-022-00599-x] - DOI - PMC - PubMed
t‐Pegram 2019 {published data only}
    1. Chen X, Li C, Ewesuedo R, Yin D. Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer. Cancer Chemotherapy and Pharmacology 2019;84(1):83-92. [DOI: 10.1007/s00280-019-03850-1] - DOI - PMC - PubMed
    1. European Medicines Agency. Assessment report of Trazimera. https://www.ema.europa.eu/en/documents/assessment-report/trazimera-epar-... (accessed prior to 3 October 2024).
    1. Li RK, Lipatov O, Adamchuk H, Vladimirov V, Yanez E, Banchero P, et al. P1-18-08: Trazimera (a trastuzumab biosimilar) in HER2-positive metastatic breast cancer: long-term safety and overall survival data. Cancer Research 2020;80(Suppl 4):P1-18-08. [DOI: 10.1158/1538-7445.SABCS19-P1-18-08] - DOI
    1. NCT01989676. A study of PF-05280014 [trastuzumab-Pfizer] or Herceptin [trastuzumab-EU] plus paclitaxel in HER2 positive first line metastatic breast cancer treatment (REFLECTIONS B327-02). clinicaltrials.gov/ct2/show/NCT01989676 (first received 21 November 2013).
    1. Pegram M, Tan-Chiu E, Freyman A, Vana A, Hilton F, Zacharchuk C, et al. A randomized double-blind study of PF-05280014 (a potential trastuzumab biosimilar) vs trastuzumab, both in combination with paclitaxel, as first-line treatment for HER2-positive metastatic breast cancer. Annals of Oncology 2017;28(Suppl 5):v74. [DOI: 10.1093/annonc/mdx365.001a] - DOI
t‐Pivot 2018 {published data only}
    1. Castan JC, Pegram M, Pivot X, Curigliano G, Lim JY, Song S, et al. Subgroup analyses of efficacy from a phase III study comparing SB3 (trastuzumab biosimilar) with reference trastuzumab in early breast cancer patients. Annals of Oncology 2018;29(Suppl 8):viii69. [DOI: 10.1093/annonc/mdy270.212] - DOI
    1. EUCTR 2015-005663-17. A long-term follow-up study for cardiac safety in the patients with HER2 positive early or locally advanced breast cancer who have completed the SB3-G31-BC. clinicaltrialsregister.eu/ctr-search/trial/2015-005663-17/results (first received 28 April 2016).
    1. EUCTR2013-004172-35-PL. A phase III randomised, double-blind, parallel group, multicentre study to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in women with newly diagnosed HER2 positive early or locally advanced breast cancer in neoadjuvant setting. clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2013-004172-35-PL (first received 12 February 2014).
    1. NCT02149524. A study to compare the effect of SB3 and Herceptin® in women with breast cancer. clinicaltrials.gov/ct2/show/NCT02149524 (first received 29 May 2014).
    1. Pegram MD, Pivot X, Cortes J, Curigliano G, Yoon Y, Lim J, et al. Abstract P6-17-09: event-free survival by ADCC status from a follow-up study comparing SB3 (trastuzumab biosimilar) with reference trastuzumab for HER2 positive breast cancer in neoadjuvant setting. Cancer Research 2019;79(Suppl 4):P6-17-09. [DOI: 10.1158/1538-7445.SABCS18-P6-17-09] - DOI
t‐Pivot 2022 {published data only}
    1. NCT03013504. A phase III trial to compare the efficacy, safety and pharmacokinetics of HD201 to Herceptin® in HER2+ early breast cancer patients. clinicaltrials.gov/ct2/show/NCT03013504 (first received 6 January 2017).
    1. Pivot X, Georgievich MA, Shamrai V, Dzagnidze G, Fen H, Kaewkangsadan V, et al. Efficacy of HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting: a multicenter phase 3 randomized clinical trial. JAMA Oncology 2022;1(8):698-705. [DOI: 10.1001/jamaoncol.2021.8171] - DOI - PMC - PubMed
    1. Pivot X, Manikhas AG, Shamrai V, Dzagnidze G, Hoo HF, Kaewkangsadan V, et al. Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting. BMC Cancer 2023;23:112. [DOI: 10.1186/s12885-023-10574-2] - DOI - PMC - PubMed
t‐Reddy 2024 {published data only}
    1. CTRI/2015/08/006085. A randomized, double-blind, multi-centre, parallel group study comparing two humanized monoclonal antibodies that target HER2 receptors in combination with weekly paclitaxel administered as first-line treatment in patients with HER2-positive metastatic breast cancer (phase 1/3). ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI1MTU=&Enc=&us... (first received 11 August 2015).
    1. Reddy N, Reddy P, Ranpura A, Maharaj N, Arora R, Mamillapalli G, et al. Efficacy, safety, pharmacokinetics, and immunogenicity of DRL-trastuzumab versus Herceptin in human epidermal growth factor receptor 2-positive metastatic breast cancer: a randomized controlled trial. JCO Global Oncology 2024;10(10):e2200328. [DOI: 10.1200/GO.22.00328] - DOI - PMC - PubMed
t‐Rugo 2017 {published data only}
    1. European Medicines Agency. Assessment report of ogivri. https://www.ema.europa.eu/en/documents/assessment-report/ogivri-epar-pub... (accessed prior to 3 October 2024).
    1. Manikhas A, Pennella EJ, Bondarenko I, Mukhametshina G, Abesamis-Tiambeng ML, Akewanlop C, et al. Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: toxicity, efficacy, and immunogenicity from the phase 3 Heritage trial. Journal of Clinical Oncology 2018;36(Suppl 15):110. [DOI: 10.1200/JCO.2018.36.15_suppl.110] - DOI
    1. NCT02472964. A multicenter, double-blind, randomized, parallel-group, phase III study of the efficacy and safety of Hercules plus taxane versus Herceptin® plus taxane as first line therapy in patients with HER2-positive metastatic breast cancer. clinicaltrials.gov/ct2/show/NCT02472964 (first received 16 June 2015).
    1. Rugo H, Barve A, Waller C, Bronchud MH, Herson J, Yuan J, et al. HERITAGE: a phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin. European Journal of Cancer 2017;72:S41.
    1. Rugo HS, Barve A, Waller CF, Hernandez-Bronchud M, Herson J, Yuan J, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer. JAMA 2017;317(1):37. [DOI: 10.1001/jama.2016.18305] - DOI - PubMed
t‐von Minckwitz 2018 {published data only}
    1. EUCTR2012-004319-29. A randomized, double-blind, phase 3 study evaluating the efficacy and safety of Abp 980 compared with trastuzumab in subjects with Her2 positive early breast cancer. clinicaltrialsregister.eu/ctr-search/search?query=2012-004319-29 (first received 3 May 2013).
    1. European Medicines Agency. Assessment report of kanjinti. https://www.ema.europa.eu/en/documents/assessment-report/kanjinti-epar-p... (accessed prior to 3 October 2024).
    1. Kolberg H-C, Colleoni M, Demetriou GS, Santi P, Tesch H, Fujiwara Y, et al. Cardiac safety of the trastuzumab biosimilar ABP 980 in women with HER2-positive early breast cancer in the randomized, double-blind, active-controlled LILAC study. Drug Safety 2020;43(3):233-42. [DOI: 10.1007/s40264-019-00886-3] - DOI - PMC - PubMed
    1. Kolberg H-C, Demetriou GS, Zhang N, Tomasevic Z, Hanes V. PD3-10: safety results from a randomized, double-blind, phase 3 study of ABP 980 compared with trastuzumab in patients with breast cancer. Cancer Research 2018;78(Suppl 4):PD3-10. [DOI: 10.1158/1538-7445.SABCS17-PD3-10] - DOI
    1. Kolberg H-C, Tomasevic Z, Demetriou G, Fujiwara Y, Colleoni M, Tesch H, et al. Efficacy analyses of central laboratory pCR results from the LILAC study comparing the biosimilar ABP 980 and trastuzumab. Journal of Clinical Oncology 2018;36(Suppl 15):583. [DOI: 10.1200/JCO.2018.36.15_suppl.583] - DOI
t‐Xu 2021 {published data only}
    1. European Medicines Agency. Assessment report of zercepac. https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac (accessed prior to 3 October 2024).
    1. Xu B, Zhang Q, Sun T, Li W, Teng Y, Bondarenko I, et al. First China-manufactured trastuzumab biosimilar HLX02 global phase III trial met primary endpoint in breast cancer. Annals of Oncology 2019;30(Suppl 9):ix185. [DOI: 10.1093/annonc/mdz446.005] - DOI
    1. Xu B, Zhang Q, Sun T, Li W, Teng Y, Hu X, et al. Efficacy and safety of first China-manufactured trastuzumab biosimilar HLX02 for metastatic breast cancer: a phase III trial. Annals of Oncology 2019;30(Suppl 5):v106. [DOI: 10.1093/annonc/mdz242] - DOI
    1. Xu B, Zhang Q, Sun T, Li W, Teng Y, Hu X, et al. Efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer: a randomized phase III equivalence trial. BioDrugs 2021;35(3):337-50. [DOI: 10.1007/s40259-021-00475-w] - DOI - PMC - PubMed

References to studies excluded from this review

Baker 2017 {published data only}
    1. Baker H. Trastuzumab biosimilar shows potential for breast cancer. Lancet Oncology 2017;18(1):e4. [DOI: 10.1016/S1470-2045(16)30638-6] - DOI - PubMed
Grohmann‐Izay 2021 {published data only}
    1. European Medicines Agency. European public assessment report (EPAR): Herwenda. https://www.ema.europa.eu/en/documents/assessment-report/herwenda-epar-p... (accessed 10 March 2024).
    1. Grohmann-Izay B, Huang C-S, Dzagnidze G, Llinás N. P2-13-17. A phase III, randomized, multicenter, double-blind study to compare efficacy and safety of EG12014 (EirGenix trastuzumab) with Herceptin as neoadjuvant treatment in combination with anthracycline/paclitaxel-based systemic therapy in patients with HER2-positive early breast cancer – a multinational phase III study conducted during the COVID-19 pandemic. San Antonio Breast Cancer Symposium; 2021 December 7-10; San Antonio (TX).
    1. NCT03433313. Efficacy and safety study of EG12014 compared with Herceptin in subjects with HER2 positive early breast cancer. clinicaltrials.gov/ct2/show/NCT03433313 (first received 14 February 2018).
NCT02771795 {published data only}
    1. NCT02771795. A long-term follow-up study for cardiac safety in the patients with HER2 (+) breast cancer who have completed the SB3-G31-BC. clinicaltrials.gov/ct2/show/NCT02771795 (first received 13 May 2016).
NCT03218072 {published data only}
    1. NCT03218072. A study to evaluate safety, tolerability, PK and PD of HLX01 in patients with CD20-positive B-cell lymphomas. clinicaltrials.gov/ct2/show/record/NCT03218072 (first received 14 July 2017).
NCT03659305 {published data only}
    1. NCT03659305. Pharmacokinetic equivalence and safety study of RPH-001 and Avastin®. clinicaltrials.gov/ct2/show/record/NCT03659305 (first received 6 September 2018).
NCT03670888 {published data only}
    1. NCT03670888. A study to compare the bioequivalence and safety of JHL1101 and rituximab in CD20 positive B cell lymphoma patients. clinicaltrials.gov/ct2/show/record/NCT03670888 (first received 14 September 2018).
NCT03670901 {published data only}
    1. NCT03670901. A study to compare the efficacy and safety of JHL1101 versus rituximab in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). clinicaltrials.gov/ct2/show/NCT03670901 (first received 14 September 2018).
NCT03755141 {published data only}
    1. NCT03755141. Efficacy and safety of trastuzumab biosimilar (Herzuma®) plus treatment of physician's choice (TPC) in patients with HER-2 positive metastatic breast cancer. clinicaltrials.gov/ct2/show/record/NCT03755141 (first received 27 November 2018).
NCT04215159 {published data only}
    1. NCT04215159. Trastuzumab biosimilar (Samfenet®) plus treatment of physician's choice (TPC) in patients with HER2-positive solid tumor. clinicaltrials.gov/ct2/show/NCT04215159 (first received 2 January 2020).
NCT04888663 {published data only}
    1. NCT04888663. Study of ramucirumab, trastuzumab and paclitaxel in patients with HER2-positive recurrent/metastatic gastric cancer (HER-RAM Study). clinicaltrials.gov/ct2/show/record/NCT04888663 (first received 17 May 2021).
RPCEC00000174 {published data only}
    1. RPCEC00000174. Evaluación del efecto y la seguridad del RituxCIM (Rituximab biosimilar) en pacientes con Linfoma no Hodgkin de células B indolente refractario o en recaída. rpcec.sld.cu/ensayos/RPCEC00000174-Sp (first received 5 November 2011).
RPCEC00000216 {published data only}
    1. RPCEC00000216. Pharmacokinetics and safety of 1B8 vs MabThera evaluation, both in combination with CHOP chemotherapy in newly diagnosed patients diffuse large B-cell lymphoma, CD 20+. rpcec.sld.cu/en/trials/RPCEC00000216-En (first received 1 September 2016).
RPCEC00000251 {published data only}
    1. RPCEC00000251. Safety and effectiveness of Cimabior® in patients with CD20-positive B-cell non-Hodgkin lymphoma. rpcec.sld.cu/en/trials/RPCEC00000251-En/revisions/3798/view (first received 5 September 2017).

References to ongoing studies

CTRI/2017/02/007892 {published data only}
    1. CTRI/2017/02/007892. Study to compare the efficacy and safety of GBR 200 (similar biologic of trastuzumab) versus innovator trastuzumab both when given in combination with paclitaxel in patients diagnosed with HER2 positive metastatic breast cancer. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17718&EncHid=&u... (first received 29 August 2017).
jRCTs071190007 {published data only}
    1. JRCTs071190007. A phase II clinical trial examining trastuzumab biosimilar (CT-P6) and chemotherapy (oxaliplatin +S-1 or oxaliplatin + capecitabine) for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy (TROX study). jrct.niph.go.jp/en-latest-detail/jRCTs071190007 (first received 17 May 2019).
NCT02879097 {published data only}
    1. NCT02879097. Efficacy-safety-immunogenicity study of CBT124 & EU-sourced Avastin® in stage 4 NSCLC. clinicaltrials.gov/ct2/show/NCT02879097 (first received 25 August 2016).
NCT03390686 {published data only}
    1. NCT03390686. A trial to compare the efficacy, safety, pharmacokinetics and immunogenecity of HD204 to Avastin® in advanced non-squamous non-small cell lung cancer patients. clinicaltrials.gov/show/NCT03390686 (first received 4 January 2018).
NCT03989037 {published data only}
    1. NCT03989037. A study of SIBP-01 or CN-trastuzumab plus docetaxel and carboplatin In HER2 positive breast cancer. clinicaltrials.gov/ct2/show/NCT03989037 (first received 18 June 2019).
NCT04361279 {published data only}
    1. NCT04361279. A study comparing SIBP-02 and rituximab combination with CHOP in previously untreated subjects with CD20+ DLBCL. clinicaltrials.gov/ct2/show/record/NCT04361279 (first received 24 April 2020).
NCT05040906 {published data only}
    1. NCT05040906. A study comparing the efficacy and safety between H-CHOP and R-CHOP in untreated CD20-positive diffuse large B-cell lymphoma patients. clinicaltrials.gov/ct2/show/NCT05040906 (first received 10 September 2021).
NCT05169801 {published data only}
    1. NCT05169801. To compare the efficacy and safety of BP102 vs. Avastin® in combination with paclitaxel/carboplatin in first-line treatment of advanced or relapsed NSCLC. clinicaltrials.gov/ct2/show/record/NCT05169801 (first received 27 December 2021).
NCT05301530 {published data only}
    1. NCT05301530. Clinical trial to assess pharmacokinetic parameters and safety of NNG-TMAB (trastuzumab) on recurrent or metastatic breast cancer patients. clinicaltrials.gov/ct2/show/record/NCT05301530 (first received 29 March 2022).
NCT05654454 {published data only}
    1. NCT05654454. A safety and efficacy study of bevacizumab, paclitaxel, carboplatin compared to Avastin® in non-small cell lung cancer. clinicaltrials.gov/ct2/show/NCT05654454 (first received 16 December 2022).

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Allahyari 2022
    1. Allahyari A, Ehsanpour A, Najafi B, Ansarinejad N, Mehrzad V, Kalantari B, et al. Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2- positive breast cancer patients: a randomized, phase III, equivalency clinical trial. BMC Cancer 22022;22:960. [DOI: 10.1186/s12885-022-09895-5] - DOI - PMC - PubMed
Bellinvia 2020
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