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      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

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          Abstract

          Trastuzumab in combination with chemotherapy has become a standard of care for patients with HER2+ breast cancer. The cost of therapy, however, can limit patient access to trastuzumab in areas with limited financial resources for treatment reimbursement. This study examined access to trastuzumab and identified potential barriers to its use in the United States, Mexico, Turkey, Russia and Brazil via physician survey. The study also investigated if the availability of a biosimilar to trastuzumab would improve access to and use of HER2 monoclonal antibody therapy. Across all countries, a subset of oncologists reported barriers to the use of trastuzumab in a neoadjuvant, adjuvant or metastatic setting. Common barriers to the use of trastuzumab included issues related to insurance coverage, drug availability and cost to the patient. Overall, nearly half of oncologists reported that they would increase the use of HER2 monoclonal antibody therapy across all treatment settings if a lower cost biosimilar to trastuzumab were available. We conclude that the introduction of a biosimilar to trastuzumab may alleviate cost-related barriers to treatment and could increase patient access to HER2-directed therapy in all countries examined.

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          GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012

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            Biosimilar therapeutics—what do we need to consider?

            Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions. The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance. Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.
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              Breast cancer: Prevention and control

              (2010)
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                Author and article information

                Journal
                Pharmaceuticals (Basel)
                Pharmaceuticals (Basel)
                pharmaceuticals
                Pharmaceuticals
                MDPI
                1424-8247
                17 September 2014
                September 2014
                : 7
                : 9
                : 943-953
                Affiliations
                [1 ]Meharry Medical College, 1005 Dr. D.B. Todd, Jr. Boulevard, Nashville, TN 37208-3599, USA
                [2 ]Early Drug Development for Innovative Therapies Division, European Institute of Oncology, Via Ripamonti, 435-20141 Milano, Italy; E-Mails: carmen.criscitiello@ 123456ieo.it (C.C.); giuseppe.curigliano@ 123456ieo.it (G.C.)
                [3 ]Pfizer Inc, 235 East 42nd St, New York, NY 10017-5755, USA; E-Mail: ira.jacobs@ 123456pfizer.com
                Author notes
                [* ]Author to whom correspondence should be addressed; E-Mail: plammers@ 123456mmc.edu ; Tel: +1-615-327-5948; Fax: +1-615-327-6733.
                Article
                pharmaceuticals-07-00943
                10.3390/ph7090943
                4190498
                25232798
                0976f00a-e1f8-472a-a559-e3f998b2eae7
                © 2014 by the authors; licensee MDPI, Basel, Switzerland.

                This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license ( http://creativecommons.org/licenses/by/3.0/).

                History
                : 03 June 2014
                : 10 September 2014
                : 12 September 2014
                Categories
                Article

                trastuzumab,biosimilar,access,emerging markets,her2+ breast cancer

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