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      Patient Preference and Adherence (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on the growing importance of patient preference and adherence throughout the therapeutic process. Sign up for email alerts here.

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      Patient attitudes and understanding about biosimilars: an international cross-sectional survey

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          Abstract

          Objective

          To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients’ willingness to try a biosimilar.

          Methods

          An international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups. Interviews were conducted in adults categorized as: 1) diagnosed: patients with inflammatory bowel disease including Crohn’s disease and ulcerative colitis, rheumatoid arthritis, psoriasis, breast cancer, lung cancer, colorectal cancer, or non-Hodgkin’s lymphoma; 2) diagnosed advocacy: individuals with these diseases who participated in patient support groups; 3) caregiver: has a loved one with these conditions and is involved in medical decisions; 4) general population: aged 18–64 years, without these conditions. Statistical analyses among groups within a region (US or EU) used column proportions test with a 95% confidence interval.

          Results

          In all, 3,198 individuals responded. Awareness about biologic therapies was significantly higher in diagnosed, diagnosed advocacy, and caregiver groups (45%–78%) versus general population (27%; P<0.05). Across all groups, awareness of biosimilars was low; only 6% of the general population reported at least a general impression of biosimilars. Awareness was significantly higher in the diagnosed advocacy group (20%–30%; P<0.05). Gaps in knowledge about biosimilars included safety, efficacy, and access to these agents. Respondents had generally positive perceptions of clinical trials, although barriers to participation were identified.

          Conclusion

          An immediate need exists for patient education about biosimilars and clinical trials to ensure educated and informed decisions are made about biosimilar use.

          Most cited references21

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          Attitudes towards clinical research amongst participants and nonparticipants.

          To investigate attitudes to clinical research amongst cancer trial participants and nonparticipants, and to compare results with those from previous studies amongst participants in noncancer trials. Trial participating respondents were given three questionnaires during the clinical trials. Respondents amongst patients declining randomization answered a single questionnaire. Participants and nonparticipants in randomized clinical cancer trials. Forty-one participants and 47 nonparticipants in cancer trials. Altruistic motives of physicians to conduct medical research were highly rated. Attitudes towards clinical research were positive in all groups, with nonparticipant respondents being the least positive. Eight to nine tenths found scientific testing necessary before general health service implementation. Trial participants were, as compared with nonparticipating respondents, more positive towards both participation of self and others. Both personal and altruistic motives for participation were highly rated. Primary reasons for nonparticipation were fear of 'the unknown' and/or unease with randomization. Only a minority felt a moral problem created by declining trial participation. Respondents amongst noncancer participants were more satisfied with the information given than both cancer participants and cancer nonparticipants. Negative experiences in cancer participants generally dealt with frustration related to seeing too many physicians at check-up appointments. Attitudes towards clinical research are generally positive even in cancer nonparticipants. Both personal and altruistic motives for participation were highly rated. A fear of 'the unknown' and resentments towards randomization were primary reasons to renounce participation. Seeing too many physicians at check-up appointments seems to be an important factor for negative experiences in cancer trial participants.
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            Developing the nation's biosimilars program.

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              Clinical considerations for the development of biosimilars in oncology

              Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term “biosimilar” refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the reference or innovator product), such that, per US Food and Drug administration draft guidelines, “no clinically meaningful differences [exist] between the biological product and the reference product in terms of safety, purity, and potency.” This article presents some considerations about the development of biosimilars in cancer treatment through an overview of biosimilars from a clinical perspective. Topics covered include the development requirements and unique regulatory requirements for biosimilars, labeling considerations, potential limitations to the uptake of biosimilars, and review of some biosimilars in development for oncology indications.
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                Author and article information

                Journal
                Patient Prefer Adherence
                Patient Prefer Adherence
                Patient Preference and Adherence
                Patient preference and adherence
                Dove Medical Press
                1177-889X
                2016
                26 May 2016
                : 10
                : 937-948
                Affiliations
                [1 ]Global Established Pharma Medicines Development Group, Pfizer Inc., New York, NY, USA
                [2 ]Global Medical Affairs, Pfizer Inc., Collegeville, PA, USA
                [3 ]Biotechnology Clinical Development, Pfizer Inc., Cambridge, MA, USA
                Author notes
                Correspondence: Ira Jacobs, Global Established Pharma Medicines Development Group, Pfizer Inc., 235 East 42nd Street, New York, NY 10017-5755, USA, Tel +1 212 733 0876, Email ira.jacobs@ 123456pfizer.com
                Article
                ppa-10-937
                10.2147/PPA.S104891
                4889091
                27307714
                8adfa090-70d7-47d8-92f0-2fbc9afb1b04
                © 2016 Jacobs et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Medicine
                patient education,cancer,treatment,biologic therapy,biosimilar,advocacy groups,inflammatory disease,oncology

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