Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis

European Medicines Agency. EMA biosimilars in the EU. Information guide for healthcare professionals. Available at: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed 20 Aug 2022.

Weise M, Bielsky MC, Smet KD, Ehmann F, Ekman N. Biosimilars: what clinicians should know. Blood. 2012. https://doi.org/10.1182/blood-2012-04-425744.

Article  Google Scholar 

European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies—non-clinical and clinical issues. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf. Accessed 20 Aug 2022.

US Food and Drug Administration. Guidance for Industry: scientific considerations in demonstrating biosimilarity to a reference product, Guidance for Industry. Available at: https://www.fda.gov/media/82647/download. Accessed 20 Aug 2022.

Stebbing J, Mainwaring PN, Curigliano G, Pegram M, Latymer M, et al. Understanding the role of comparative clinical studies in the development of oncology biosimilar. J Clin Oncol. 2020;38(10):1070-80. https://doi.org/10.1200/JCO.19.02953.

Article  CAS  Google Scholar 

US Food and Drug Administration. Guidance for Industry: considerations in demonstrating interchangeability with a reference product. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry. Accessed 20 Aug 2022.

Yang J, Yu S, Yang Z, Yan Y, Chen Y, Zeng H, et al. Efficacy and safety of anti-cancer biosimilars compared to reference biologics in oncology: a systematic review and meta-analysis. BioDrugs. 2019;33:357–71. https://doi.org/10.1007/s40259-019-00358-1.

Article  Google Scholar 

Chiumente M, Mengato D, Messori A. Rituximab biosimilar evaluated by network meta-analysis. Haematologica. 2017;102. https://doi.org/10.3324/haematol.2017.175042.

Mengato D, Chimente M, Messori A. Trastuzumab biosimilar in metastatic breast cancer: evaluating equivalence with originator using network meta-analysis. Int J Clin Pharmacol Ther. 2019;57(3):160–62. https://doi.org/10.5414/CP203351.

Article  Google Scholar 

Liu T, Liu D, Jin Y, Dong M. Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis. Immunopharmacol Immunotoxicol. 2022;44(6):809–15. https://doi.org/10.1080/08923973.2022.2090956.

Article  CAS  Google Scholar 

Lee S, Lee H, Kim E. Comparative efficacy and safety of biosimilar rituximab and originator rituximab in rheumatoid arthritis and non-Hodgkin’s lymphoma: a systematic review and meta-analysis. BioDrugs. 2019;33(5):469–83. https://doi.org/10.1007/s40259-019-00376-z.

Article  Google Scholar 

Efficacy and safety of bevacizumab biosimilars compared with reference biologics in advanced non-small cell lung cancer or metastatic colorectal cancer patients: a network meta-analysis. Front Pharmacol. 2022;13. https://doi.org/10.3389/fphar.2022.880090.

European Medicines Agency. Neulasta scientific discussion. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/neulasta-epar-scientific-discussion_en.pdf. Accessed 17 July 2022.

US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Available at: https://www.fda.gov/media/82647/download. Accessed 15 Nov 2022.

European Medicines Agency. Concept paper on extrapolation of efficacy and safety in medicine development. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-extrapolation-efficacy-safety-medicine-development_en.pdf. Accessed 15 Nov 2022.

Yang J, Yu S, Yang Z, Yan Y, Chen Y, Zeng H, et al. Efficacy and safety of supportive care biosimilars among cancer patients: a systemic review and meta-analysis. BioDrugs. 2019;33:373–89. https://doi.org/10.1007/s40259-019-00356-3.

Article  Google Scholar 

Thorlund K, Imberger G, Johnston BC, Walsh M, Awad T, Thanbane L, et al. Evolution of heterogeneity (I2) estimates and their 95% confidence intervals in large meta-analyses. PLoS ONE. 2012;7(7). https://doi.org/10.1371/journal.pone.0039471.

Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, et al. PF-06439535 (a bevacizumab biosimilar) compared with reference bevacizumab (Avastin®), both plus paclitaxel and carboplatin, as first-line treatment for advanced non-squamous non-small-cell lung cancer: a randomized, double-blind study. BioDrugs. 2019;33:555–70. https://doi.org/10.1007/s40259-019-00363-4.

Article  CAS  Google Scholar 

Trukhin D, Poddubskaya E, Andric Z, Makharadze T, Bellala RS, Charoentum C, et al. Efficacy, safety and immunogenicity of MB02 (bevacizumab biosimilar) versus reference bevacizumab in advanced non-small cell lung cancer: a randomized, double-blind, phase III study (STELLA). BioDrugs. 2021;35(4);429–44. https://doi.org/10.1007/s40259-021-00483-w.

Article  CAS  Google Scholar 

Qin S, Li J, Bai Y, Shu Y, Li W, Yin X, et al. Efficacy, safety, and immunogenicity of HLX04 versus reference bevacizumab in combination with XELOX or mFOLFOX6 as first-line treatment for metastatic colorectal cancer: results of a randomized, double-blind phase III study. BioDrugs. 2021;35:445–58. https://doi.org/10.1007/s40259-021-00484-9.

Article  CAS  Google Scholar 

Syrigos K, Abert I, Andric Z, Bondarenko IN, Dvorkin M, Galic K, et al. Efficacy and safety of bevacizumab biosimilar FKB238 versus originator bevacizumab: results from AVANA, a phase III trial in patients with non-squamous non-small-cell lung cancer (non-sq-NSCLC). BioDrugs. 2021:35;417–28. https://doi.org/10.1007/s40259-021-00489-4.

Article  CAS  Google Scholar 

Shi Y, Lei K, Jia Y, Ni B, He Z, Bi M, et al. Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: a multicenter, randomized, double-blinded, phase III trial. Cancer Commun. 2021;14(9):889–903. https://doi.org/10.1002/cac2.12179.

Article  Google Scholar 

Chu T, Lu J, Bi M, Zhang H, Zhuang W, Yu Y, et al. Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial. Cancer Biol Med. 2021;18(3):816–24. https://doi.org/10.20892/j.issn.2095-3941.2020.0212.

Article  CAS  Google Scholar 

Apsangikar PD, Chaudhry SR, Naik MM, Deoghare SB, Joseph J. Comparative pharmacokinetics, efficacy, and safety of bevacizumab biosimilar to reference bevacizumab in patients with metastatic colorectal cancer. Indian J Cancer. 2017;54(3):535–8.

Article  Google Scholar 

Socinski MA, Waller CF, Idris T, Bondarenko I, Luft A, Beckmann K, et al. Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer. Ther Adv Med Oncol. 2021;13:1–16. https://doi.org/10.1177/17588359211045845.

Article  CAS  Google Scholar 

Thatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Rodriguez LP, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced non-squamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019;25(7);2088–95. https://doi.org/10.1158/1078-0432.CCR-18-2702.

Article  CAS  Google Scholar 

Romera A, Peredpaya S, Shparyk Y, Bondarenko I, Bariani GM, Abdalla KC, et al. Bevacizumab biosimilar BEVZ92 versus reference bevacizumab in combination with FOLFOX or FOLFIRI as first-line treatment for metastatic colorectal cancer: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018;3:845–55. https://doi.org/10.1016/S2468-1253(18)30269-3.

Article  Google Scholar 

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. Transl Lung Cancer Res. 2019;8(6):989–99. https://doi.org/10.21037/tlcr.2019.12.23.

Article  CAS  Google Scholar 

Reck M, Luft A, Bondarenko I, Shevnia S, Trukhin D, Kovalenko NV, et al. A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. Lung Cancer. 2020;146:12–18. https://doi.org/10.1016/j.lungcan.2020.05.027.

Article  Google Scholar 

Advani S, Biswas G, Sinha S, B B, Bandi VK, Naidu N, et al. A prospective, randomized, multiple-dose, multi-center comparative clinical study to evaluate the efficacy, safety, immunogenicity of a biosimilar bevacizumab (test product, hetero) and reference medicinal product (bevacizumab, roche) in patients of metastatic colorectal cancer. J Assoc Phys India. 2018;66(5):55–59.

Rezvani H, Mortazavizadeh SM, Allahyari A, Nekuee A, Najafi SN, Vahidfar M, et al. Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: a phase III, randomized, double-blind, noninferiority clinical trial. Clin Ther. 2020;42(5):848–59. https://doi.org/10.1016/j.clinthera.2020.03.009.

Article  CAS  Google Scholar 

Wan R, Dong X, Chen Q, Yu Y, Yang S, Zhang X, et al. 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. EClinicalMedicine. 2021;42(5):1023. https://doi.org/10.1016/j.eclinm.2021.101187.

Article  Google Scholar 

Stroyakovskiy D, Fadeeva NV, Matrosova MP, Shelepen KG, Adamchuk GA, Roy B, et al. Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab. BMC Cancer. 2020;22:129. https://doi.org/10.1186/s12885-022-09243-7.

Article  CAS  Google Scholar 

Kim WS, Buske C, Ogura M, Jurczak W, Sancho JM, Zhavrid E, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017;4(8):E362–73. https://doi.org/10.1016/S2352-3026(17)30120-5.

Article  Google Scholar 

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 Chemother Pharmacol. 2019;84(4):839–47. https://doi.org/10.1007/s00280-019-03920-4.

Article  CAS  Google Scholar 

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. https://doi.org/10.1007/s40259-021-00475-w.

Article  CAS  Google Scholar 

Minchwitz G, Colleoni M, Kolberg HC, Morales S, Santi P, Tomasevic Z, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, Phase 3 trial. Lancet Oncol. 2018;19(9):987–98. https://doi.org/10.1016/S1470-2045(18)30241-9.

Article  Google Scholar 

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. https://doi.org/10.1186/s12885-020-07247-9.

Article  CAS  Google Scholar 

Pegram MD, Bondarenko I, Zorzetto MM, Hingmire S, Iwase H, Krivorotko PV, et al. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study. Br J Cancer. 2019;120(2):172–82.

Article  CAS  Google Scholar 

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. Br J Cancer. 2018;119: 266–73. https://doi.org/10.1038/s41416-018-0147-1.

Article  CAS  Google Scholar 

Apsangikar PD, 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 J Cancer. 2017;54(4):664–8.

Article  Google Scholar 

Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn JH, et al. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results. Eur J Cancer. 2018;93:19–27. https://doi.org/10.1016/j.ejca.2018.01.072.

Article  CAS  Google Scholar 

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: a randomized clinical trial. JAMA. 2017;317(1):37–47. https://doi.org/10.1001/jama.2016.18305.

Article  CAS  Google Scholar 

Li RK, Tokunaga E, Adamchuk H, Vladimirov V, Yanez E, Lee KS, et al. Long-term safety and effectiveness of PF-05280014 (a trastuzumab biosimilar) treatment in patients with HER2-positive metastatic breast cancer: updated results of a randomized, double-blind study. BioDrugs. 2020;36(1):55–69. https://doi.org/10.1007/s40259-021-00513-7.

Article  CAS  Google Scholar 

Pivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, et al. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019;120:1–9. https://doi.org/10.1016/j.ejca.2019.07.015.

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