Biosimilars for breast cancer

References

• Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28:1053–1058.
   PubMed Web of Science ®Google Scholar
• Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2018;19:411–419.
   Web of Science ®Google Scholar
• Hirsch BR, Lyman GH. Biosimilars: are they ready for primetime in the United States? J Natl Compr Canc Netw. 2011;9:934–942.
   PubMed Web of Science ®Google Scholar
• American Cancer Society. Cancer Facts & Figures. 2018. American Cancer Society, Atlanta, 2018.
   Google Scholar
• Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744–3752.
   PubMed Web of Science ®Google Scholar
• Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Herceptin adjuvant (HERA) trial study team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2015;353(16):1659–1672.
   Web of Science ®Google Scholar
• Slamon D, Eiermann W, Robert N, et al. Breast cancer international research group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273–1283.
   PubMed Web of Science ®Google Scholar
• Slamon D, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpress HER2. N Engl J Med. 2001;344(11):783–792.
   PubMed Web of Science ®Google Scholar
• Pegram M, Slamon D. Biological rationale for HER-2/neu (C-erbB2) as a target for monoclonal antibody therapy. Semin Oncol. 2000;27(5 suppl 9):13–19.
   PubMed Web of Science ®Google Scholar
• US FDA. Full prescribing information for herceptin (Trastuzumab). Available from: https://www.accessdata.fda.gov/drugsatfda_doc/label/2010/10392s5250lbl.pdf
   Google Scholar
• Blackwell K, Gligorov J, Jacos I, et al. The global need for trastuzumab biosimilar for patients with HER2-positive breast cancer. Clin Breast Cancer. 2018;18:95–113.
   PubMed Web of Science ®Google Scholar
• Chavarri-Guerra Y, Louis J, Bukowski A, et al. Real world patterns of care in HER2-overexpressing breast cancer: results of a survey of TEACH clinical trial investigators in 2011. Breast. 2017;31:197–201.
   PubMed Web of Science ®Google Scholar
• Debiase M, Reinert T, Kaliks R, et al. Estimation of premature deaths from lack of access to anti-HER2 therapy for advanced breast cancer in the Brazilian public health system. J Glob Oncol. 2017;3:201–207.
   PubMed Web of Science ®Google Scholar
• FDA information on Biosimilars. Food and Drug Administartion. 2018.
   Google Scholar
• Uifalen A, Ilies M, Nicoara R, et al. Concepts and challenges of biosimilars in breast cancer: the emergence of trastuzumab biosimilars. Pharmaceut. 2018;10(168):1–13.
   Google Scholar
• EMA and EU. Biosimilars in the EU. Information guide for healthcare professionals. Available from: http://www.ema.europa.eu/docs/en_GB7document_library/leaflet/2017/05/WC500226648.pdf
   Google Scholar
• Vezer B, Buzas Z, Sebeszta M, et al. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32:829–834.
   PubMed Web of Science ®Google Scholar
• Pietras R, Pegram M, Finn R, et al. Remission of human breast cancer xenografts on therapy with humanized monoclonal antibody to HER-2 receptor and DNA-reactive drugs. Oncogene. 1998;17:2235–2249.
   PubMed Web of Science ®Google Scholar
• Li E, Ramanan S, Green L. Pharmacist substitution of biological products; issues and considerations. JMCP. 2015;21:532–539.
   PubMed Web of Science ®Google Scholar
• Glassy MC, Gupta R. Technical and ethical limitations in making human monoclonal antibodies (an overview). Methods Mol Biol. 2014;1060:3–36.
   Google Scholar
• Laslop A. Biosimilar monoclonal antibodies-challenges and opportunities in Europe. GaBI J. 2013;2:110–111.
   Google Scholar
• Martin K. European Experience with biosimilars. Santo Member of Polpharma Group; 2015.
   Google Scholar
• Bang YJ, Van Cutsem E, Feyereislova A. et al. ToGA trial investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER-2 positive advanced gastric cancer or gastro-oesophageal junction cancer: a phase 3, open label, randomized controlled trial. Lancet. 2010;376(9742):687–697.
   PubMed Web of Science ®Google Scholar
• EMA recommends approval for biosimilar bevacizumab. Available from: https://www.esmo.org/Oncology-News/EMA-Recommends-Approval-of-Biosimilar-Bevacizumab
   Google Scholar
• Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study). N Engl J Med. 2015;372:724–734.
   PubMed Web of Science ®Google Scholar
• Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of (neo)adjuvante trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open label, milticenter, randomised trial. Lancet Oncol. 2012;13:869–878.
   PubMed Web of Science ®Google Scholar
• US food and drug administration. Guidance for industry: pathologic complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an end point to support accelerated approval. 2012.
   Google Scholar
• Jackisch C, Acappaticci F, Heinzmann D, et al. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation. Future Oncol. 2015;11(1):31–71.
   Web of Science ®Google Scholar
• Rugo H, Barve A, Walker C, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with HER2 positive metastatic breast cancer – A randomized trial. JAMA. 2017;317(1):37–47.
   PubMed Web of Science ®Google Scholar
• Manikhas A, Pennella AJ, Bondarenko I, et al. Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: toxicity, efficacy, and immunogenicity from the phase 3 Heritage trial. J Clin Oncol. 2018;36(15_suppl):110.
   Web of Science ®Google Scholar
• Available from: https://www.medicines.org.uk/emc/product/9047
   Google Scholar
• Pivot X, Bondarenko I, Nowecki Z, et al. Phase IIi, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of sb3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2–positive early breast cancer. J Clin Oncol. 2018;36:968–974.
   PubMed Web of Science ®Google Scholar
• Esteva F, Saeki T, Kim H, et al. Efficacy and safety of the trastuzumab biosimilar candidate CT-P6. Future Med. 2018;14(19):1909–1919.
   Google Scholar
• Minckwitz GV, Colleoni M, Kolberg HC, 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;19:987–998.
   PubMed Web of Science ®Google Scholar
• Available from https://www.pfizer.com/news/pressrelease/presrelease_detail/pfizer_receives_positivechmp_opinion-for-oncology-biosimilar-trazimera-trastuzumb
   Google Scholar
• Pegram M, Bondarenko I, Zorzetto MMC, 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. BMJ. 2018 Dec 20. Published online.
   Google Scholar