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      Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

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          Abstract

          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.

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          Most cited references3

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          Brand Loyalty, Generic Entry and Price Competition in Pharmaceuticals in the Quarter Century after the 1984 Waxman-Hatch Legislation

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            Is Open Access

            Clinical trials for authorized biosimilars in the European Union: a systematic review

            Aim In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. The present study compared the clinical trials undertaken to obtain market authorization. Methods We summarized the findings of a comprehensive review of all clinical trials up to market authorization of approved biosimilars, using the European public assessment reports (EPARs) published by the European Medicines Agency (EMA). The features compared were, among others, the number of patients enrolled, the number of trials, the types of trial design, choice of endpoints and equivalence margins for pharmacokinetic (PK)/pharmacodynamic (PD) and phase III trials. Results The variability between the clinical development strategies is high. Some differences are explainable by the characteristics of the product; if, for example, the PD marker can be assumed to predict the clinical outcome, no efficacy trials might be necessary. However, even for products with the same reference product, the sample size, endpoints and statistical models are not always the same. Conclusions There seems to be flexibility for sponsors regarding the decision as to how best to prove biosimilarity.
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              Clinical trials for authorized biosimilars in the European Union: a systematic review

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                Author and article information

                Contributors
                hillel.cohen@sandoz.com
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                31 October 2016
                31 October 2016
                2017
                : 33
                : 12
                : 2160-2172
                Affiliations
                [1 ]Sandoz Inc., Princeton, NJ USA
                [2 ]Merck & Co., Inc., Kenilworth, NJ USA
                [3 ]Amgen, Thousand Oaks, CA USA
                [4 ]Feinstein Kean Healthcare, New York, NY USA
                [5 ]Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA
                [6 ]Ares Trading SA, Aubonne, Switzerland
                [7 ]Pfizer Inc., New York, NY USA
                Article
                431
                10.1007/s12325-016-0431-5
                5126187
                27798772
                3ee3f6a3-711a-4a31-a37f-13622bc9441c
                © The Author(s) 2016
                History
                : 16 September 2016
                Funding
                Funded by: Biosimilars Forum
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare 2016

                biologic,biosimilar,biosimilarity,extrapolation,immunogenicity,interchangeability,originator biologic

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