Abstract
First biosimilars of monoclonal antibodies have recently been approved in oncology. Biosimilars enable economic competition, alleviate the financial burden for insurances, and may facilitate access to these drugs in low-income countries. Biosimilars are not completely identical to the original drug. The approval of biosimilars is only partially based on results of randomized clinical studies. In the introduction phase of new biosimilars, this can lead to uncertainties for patients and physicians. Based on the current clinical data and experiences, biosimilars of monoclonal antibodies in oncology show no significant differences in pharmacokinetics, efficacy, and safety in comparison to the patented originals. Scientific medical societies recommend the use of biosimilar monoclonal antibodies and support switching in long-term treatments. However, the use of biosimilars for off-label indications requires additional attention towards efficacy and safety. Active counselling of the patient by the treating physician is the most important step in the informed consent process, especially when switching from an original to a biosimilar. Careful documentation of the prescribed drug and enhanced pharmacovigilance are recommended for the use of biosimilars.
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References
1.
European Medicines Agency: Guideline on similar biological medicinal products, 23 Oct 2014. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.
2.
World Health Organization: Expert committee on biological standardization. Geneva, 17-21 October 2016. Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). www.who.int/biologicals/expert_committee/mAb_SBP_GL-ECBS_review_adoption-2016.10.26-11.7post_ECBS-Clean_Version.pdf.
3.
Schellekens H: Biosimilar therapeutic agents: issues with bioequivalence and immunogenicity. Eur J Clin Invest 2004;34:797-799.
[PubMed]
4.
Casadevall N: Pure red cell aplasia and anti-erythropoietin antibodies in patients treated with epoetin. Nephrol Dial Transplant 2003;18(suppl 8):viii37-41.
[PubMed]
5.
Maloney DG, Grillo-López AJ, White CA, et al: IDEC-C2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997;90:2188-2195.
[PubMed]
6.
McLaughlin P, Grillo-López AJ, Link BK, et al: Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16:2825-2833.
[PubMed]
7.
Baselga J, Tripathy D, Mendelsohn J, et al: Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996;14:737-744.
[PubMed]
8.
European Medicines Agency: Truxima. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004112/human_med_002077.jsp.
9.
European Medicines Agency: Meeting highlights from the Committee for Medicinal Products for Human Use (CJMP) 18-21 April 2017. www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/04/news_detail_002732.jsp&mid=WC0b01ac058004d5c1.
10.
Cohen S, Kay J: Biosimilars: implications for rheumatoid arthritis therapy. Curr Opin Rheumatol 2017;29:260-268.
[PubMed]
11.
Vencovsky J, Sylwestrzak A, Leszczyñski P, et al: A phase III, randomized, double-blind clinical study comparing SB4, an etanercept biosimilar, with etanercept reference product (Enbrel®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (52-week results); in 2015 ACR/ARHP Annual Meeting Abstract Supplement. Arthritis Rheumatol 2015;67(suppl 10):abstr 2055.
12.
Choe JY, Prodanovic N, Niebrzydowski J, et al: A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:58-64.
[PubMed]
13.
Jørgensen K, Olsen I, Goll G, et al: LB15 - biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from the 52-week randomized NOR-SWITCH trial. Abstract presented at the United European Gastroenterology (UEG) Week meeting 2016, 15-19 October, Vienna, Austria.
[PubMed]
14.
Rugo H, Barve A, Waller CF, et al.; Heritage Study Investigators: 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;317:37-47.
[PubMed]
15.
Tabernero J, Vyas M, Giuliani R, et al: Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open 2017;1:e000142.
16.
DGHO 2017: Positionspapier: Biosimilars von monoklonalen Antikörpern in der Medizinischen Onkologie. www.dgho.de/publikationen/stellungnahmen/gute-aerztliche-praxis/copy_of_biosimilars/Biosimilars%20Positionspapier_FINAL.pdf/view.
17.
Schwabe U, Paffrath D: Arzneiverordnungs-Report 2016. www.wido.de/fileadmin/wido/downloads/pdf_arzneimittel/wido_arz_avr2016_pk_0916.pdf.
18.
Flume M: Regional management of biosimilars in Germany. GaBI Journal 2017;5:125-127.
19.
www.aerzteblatt.de/pdf/111/11/a452.pdf.
20.
Freund M, Rottmann M, Wilhelm M: Medikamentöse Tumortherapie: Anordnung, Durchführung und Nachsorge, Onkopedia, 2012. www.onkopedia.com/de/onkopedia/guidelines/medikamentoese-tumortherapie-anordnung-durchfuehrung-und-nachsorge/@@view/html/index.html.
21.
Frühe Nutzenbewertung neuer Arzneimittel in der Onkologie und Hämatologie, 2011-2016. Analysen und Impulse. Gesundheitspolitische Schriftenreihe der DGHO, Band 10, 2017.
22.
Jurczak W, Ilidia M, Govindbabu KS, 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;128:1809.
23.
Coiffier B, Sancho J-M, Jurcza W, 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;128:1807.
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