Abstract
Physician awareness and perceptions towards biosimilars are important factors in their adoption to clinical practice. Our objectives were to assess levels of knowledge and attitudes towards biosimilars and key policies on their use among Russian physicians, define the level of interest in new information on biosimilars, and determine what evidence drives treatment decisions in Russia. Physicians with awareness of biologics across different specialties and regions of Russia completed an online survey. A Likert and other rating scales were used to collect opinions, which were summarized descriptively. Responses of subgroups of respondents were compared using t-tests. Among 206 respondents (n = 51 rheumatologists; n = 53 gastroenterologists; n = 50 hematologists; n = 52 oncologists), 66% had positive impressions regarding the introduction of biosimilars in Russia. Overall, 80% lacked understanding of the differences between biosimilars and generics. In all, 67% supported prescribing biologics by distinguishable names and were negative about tender policies limiting choice of therapies for patients. The majority believed in mandatory publication of clinical trial results on biosimilars (94%), agreed biosimilars should be subject to rigorous post-marketing surveillance (98%), and expressed willingness to learn more about biosimilars (94%). Biosimilar education among Russian physicians is required, which may help shape balanced and evidence-based policies for biosimilars in Russia.
Highlights
Biologic therapies have revolutionized treatment for many life-threatening and debilitating diseases; patient access to these medicines can be restricted [1]
Biosimilars are biologic products that are highly similar to a licensed reference biologic with respect to their quality characteristics, pharmacology, efficacy and safety, such that there are no meaningful differences between the biosimilar and reference product when used in clinical practice [4,5,6]
Among 210 physicians who were screened by telephone, 43% had prescribed biologic therapies in the past 12 months and were familiar with biosimilars
Summary
Biologic therapies have revolutionized treatment for many life-threatening and debilitating diseases; patient access to these medicines can be restricted [1]. The recent expiry of patent portfolios for the first innovator biopharmaceuticals (reference products) has led to the development and authorization of similar biological medicinal products, known as biosimilars [2,3]. But not identical, to their reference products, they cannot be considered generic versions of biologic drugs. The regulatory approval process for generic medicines is not applicable to biosimilars [7]. The European Medicines Agency and World Health Organization (WHO) [4,5], as well as a number of countries [6,8], have issued guidance on biosimilar regulatory pathways. Approval of biosimilars requires comprehensive assessment of all stages of the research and development process, Biomolecules 2019, 9, 57; doi:10.3390/biom9020057 www.mdpi.com/journal/biomolecules
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