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

Pharmaceuticals

Volumn 7, Issue 9, 2014, Pages 943-953

  Lammers, Philip ^a   Criscitiello, Carmen ^b   Curigliano, Giuseppe ^b   Jacobs, Ira ^c  

^a MEHARRY MEDICAL COLLEGE   (United States)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^c PFIZER INC   (United States)

Author keywords

Access; Biosimilar; Emerging markets; HER2+ breast cancer; Trastuzumab

Indexed keywords

BIOSIMILAR AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; MONOCLONAL ANTIBODY; TRASTUZUMAB;

ARTICLE; BRAZIL; BREAST CANCER; BREAST METASTASIS; CANCER ADJUVANT THERAPY; DRUG COST; DRUG USE; HEALTH CARE ACCESS; HEALTH CARE AVAILABILITY; HEALTH INSURANCE; HUMAN; MEXICO; ONCOLOGIST; RUSSIAN FEDERATION; TURKEY (REPUBLIC); UNITED STATES;

EID: 84928107043     PISSN: None     EISSN: 14248247     Source Type: Journal    
DOI: 10.3390/ph7090943     Document Type: Article

References (25)

1. International Agency for Research on Cancer (IARC) and World Health Organization (WHO). GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available online: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (accessed on 18 March 2014).
2. Siegel, R.; Ma, J.; Zou, Z.; Jemal, A. Cancer statistics, 2014. CA Cancer J. Clin. 2014, 64, 9–29.
3. Coleman, M.P.; Quaresma, M.; Berrino, F.; Lutz, J.M.; de Angelis, R.; Capocaccia, R.; Baili, P.; Rachet, B.; Gatta, G.; Hakulinen, T., et al. Cancer survival in five continents: A worldwidepopulation-based study (CONCORD). Lancet Oncol. 2008, 9, 730–756.
4. World Health Organization (WHO). Breast Cancer: Prevention and Control. Available online: http://www.who.int/cancer/detection/breastcancer/en/index1.html (accessed on 6 February 2014).
5. Genentech. Herceptin US prescribing information. Available online: http://www.gene.com/download/pdf/herceptin_prescribing.pdf (accessed on 6 February 2014).
6. European Medicines Agency. Herceptin EU Prescribing Information. Available online: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf (accessed on 18 March 2014).
7. Piccart-Gebhart, M.J.; Procter, M.; Leyland-Jones, B.; Goldhirsch, A.; Untch, M.; Smith, I.; Gianni, L.; Baselga, J.; Bell, R.; Jackisch, C., et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N. Engl. J. Med. 2005, 353, 1659–1672.
8. Romond, E.H.; Perez, E.A.; Bryant, J.; Suman, V.J.; Geyer, C.E., Jr.; Davidson, N.E.; Tan-Chiu, E.; Martino, S.; Paik, S.; Kaufman, P.A., et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N. Engl. J. Med. 2005, 353, 1673–1684.
9. Slamon, D.J.; Leyland-Jones, B.; Shak, S.; Fuchs, H.; Paton, V.; Bajamonde, A.; Fleming, T.; Eiermann, W.; Wolter, J.; Pegram, M., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 2001, 344, 783–792.
10. Gianni, L.; Pienkowski, T.; Im, Y.H.; Roman, L.; Tseng, L.M.; Liu, M.C.; Lluch, A.; Staroslawska, E.B.; de la Haba-Rodriguez, J.; Im, S.A., et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): A randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012, 13, 25–32.
11. Schellekens, H. Biosimilar therapeutics-what do we need to consider? NDT Plus 2009, 2, i27–i36.
12. Zelenetz, A.D.; Ahmed, I.; Braud, E.L.; Cross, J.D.; Davenport-Ennis, N.; Dickinson, B.D.; Goldberg, S.E.; Gottlieb, S.; Johnson, P.E.; Lyman, G.H., et al. NCCN biosimilars white paper: Regulatory, scientific, and patient safety perspectives. J. Nat. Compr. Canc. Netw. 2011, 9, S1–S22.
13. Cai, X.; Wake, A.; Gouty, D. Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development. Bioanalysis 2013, 5, 517–520.
14. Megerlin, F.; Lopert, R.; Taymor, K.; Trouvin, J.H. Biosimilars and the European experience: Implications for the United States. Health Aff. (Millwood) 2013, 32, 1803–1810.
15. Patient Protection and Affordable Care Act of 2009, Pub. L. No. 111–148, Title VII, Improving access: Biologics Price Competition and Innovation Act of 2009, Section 7001–7003.
16. European Medicines Agency. Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Product. Available online: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500117987.pdf (accessed on 18 March 2014).
17. Tatar, M.; Mollahaliloglu, S.; Sahin, B.; Sabahattin, A.; Maresso, A.; Hernandez-Quevedo, C. Turkey Helath System Review. Health Syst. Transit. 2011, 13, 1–186.
18. Popovich, L.; Potapchik, E.; Shishkin, S.; Richardson, E.; Vacroux, A.; Mathivet, B. Russian Federation Health System Review. Health Syst. Transit. 2011, 13, 1–190.
19. Paim, J.; Travassos, C.; Almeida, C.; Bahia, L.; Macinko, J. The Brazilian health system: History, advances, and challenges. Lancet 2011, 377, 1778–1797.
20. The Organisation for Economic Co-operation and Development. OECD Reviews of Health Systems: Mexico. Available online: http://www.borderhealth.org/files/res_839.pdf (accessed on 21 July 2014).
21. Patient Protection and Affordable Care Act of 2009, Pub. L. No. 111–148.
22. Lopes, G. Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India. Ann. Oncol. 2013, 24, v13–v16.
23. Qureshi, Z.P.; Magwood, J.S.; Singh, S.; Bennett, C.L. Rituximab and biosimilars—Equivalence and reciprocity. Biosimilars 2013, 3, 19–25.
24. Merron, A. Biosimilars advisory Service: Physician Perspectives on G-CSFs and Monoclonal Antibodies in Oncology Available online: http://bio-trends.com/Products-and-Services/Report?r=basxxx0113 (accessed on 19 March 2014).
25. Bang, Y.J.; van Cutsem, E.; Feyereislova, A.; Chung, H.C.; Shen, L.; Sawaki, A.; Lordick, F.; Ohtsu, A.; Omuro, Y.; Satoh, T., et al. Trastuzumab in combination with chemotherapy vs. chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): A phase 3, open-label, randomised controlled trial. Lancet 2010, 376, 687–697.