3
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background:

          In July 2019, bevacizumab-awwb and trastuzumab-anns were marketed in the USA as the first therapeutic oncology biosimilars. We aimed to investigate the initial real-world use of bevacizumab-awwb and trastuzumab-anns for cancer management in US oncology practices.

          Methods:

          A retrospective, observational analysis of data from US cancer patients (⩾18 years of age) was carried out to describe the use of bevacizumab-awwb and trastuzumab-anns during the first 12 months following their market entry, using structured data from the Flatiron Health electronic health record-derived database.

          Results:

          A total of 2952 and 2997 patients with recorded use of bevacizumab-awwb and trastuzumab-anns, respectively, were included in the analysis. The first use of bevacizumab-awwb and trastuzumab-anns was in a patient with metastatic colorectal cancer (mCRC) within 10 days of market availability and in a patient with early stage breast cancer (eBC) within 4 days, respectively. The use of these biosimilars was observed across all approved cancer indications; 68% of bevacizumab-awwb users were those diagnosed with mCRC and 72% of trastuzumab-anns users were those diagnosed with eBC. Approximately half the patients were previously exposed to reference product (RP) prior to initiation of bevacizumab-awwb or trastuzumab-anns. Among pre-exposed patients, the majority received the biosimilars [bevacizumab-awwb (63–85%) or trastuzumab-anns (75–81%)] within 28 days of the last infusion of the RP. For both biosimilars, no major differences were observed in patient characteristics between RP-naïve and pre-exposed patients.

          Conclusion:

          Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups.

          A video abstract is available for this article as part of the Kanjintionline supplemental material.

          Related collections

          Most cited references30

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making

          Evidence from medication use in the real world setting can help to extrapolate and/or augment data obtained in randomized controlled trials and establishes a broad picture of a medication’s place in everyday clinical practice. By supplementing and complementing safety and efficacy data obtained in a narrowly defined (and often optimized) patient population in the clinical trial setting, real world evidence (RWE) may provide stakeholders with valuable information about the safety and effectiveness of a medication in large, heterogeneous populations. RWE is emerging as a credible information source; however, there is scope for enhancements to real world data (RWD) sources by understanding their complexities and applying the most appropriate analytical tools in order to extract relevant information. In addition to providing information for clinicians, RWE has the potential to meet the burden of evidence for regulatory considerations and may be used in approval of new indications for medications. Further understanding of RWD collection and analysis is needed if RWE is to achieve its full potential.
            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

              Introduction The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2–3 years in order to monitor trends over time. Methods A 19-question survey was created by the Biosimilars Forum and was administered by an independent third party. Results Responses were obtained from 1201 US physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists, and rheumatologists. Conclusions The results of this survey highlight a significant need for evidence-based education about biosimilars for physicians across specialties. Five major knowledge gaps were identified: defining biologics, biosimilars, and biosimilarity; understanding the approval process and the use of “totality of evidence” to evaluate biosimilars; understanding that the safety and immunogenicity of a biosimilar are comparable to the originator biologic; understanding the rationale for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution. Funding : Biosimilars Forum. Electronic supplementary material The online version of this article (doi:10.1007/s12325-016-0431-5) contains supplementary material, which is available to authorized users.
                Bookmark

                Author and article information

                Contributors
                Journal
                Ther Adv Med Oncol
                Ther Adv Med Oncol
                TAM
                sptam
                Therapeutic Advances in Medical Oncology
                SAGE Publications (Sage UK: London, England )
                1758-8340
                1758-8359
                1 September 2021
                2021
                : 13
                : 17588359211041961
                Affiliations
                [1-17588359211041961]Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA
                [2-17588359211041961]Sylvester Cancer Center, University of Miami, Deerfield Beach, FL, USA
                [3-17588359211041961]Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA
                [4-17588359211041961]US Medical Assets, Amgen Inc., Thousand Oaks, CA, USA*Joint first authors
                [5-17588359211041961]US Medical Assets, Amgen Inc., Thousand Oaks, CA, USA*Joint first authors
                [6-17588359211041961]Department of Medical Oncology, Cancer Treatment Centers of America, Comprehensive Care and Research Center, 600 Celebrate Life Parkway, Newnan, GA 30265, USA
                Author notes
                Article
                10.1177_17588359211041961
                10.1177/17588359211041961
                8734207
                eaa424f3-a70b-4a78-905d-068f7a004e4c
                © The Author(s), 2021

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 28 January 2021
                : 9 August 2021
                Categories
                Original Research
                Custom metadata
                January-December 2021
                ts1

                bevacizumab-awwb,biosimilar,clinical characteristics,kanjinti,mvasi,oncology biosimilar,real-world data,trastuzumab-anns,treatment patterns

                Comments

                Comment on this article