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A WEB-BASED SURVEY TO INVESTIGATE THE EXTENT OF AWARENESS AND UNDERSTANDING FOR BIOSIMILAR AMONG JAPANESE PHYSICIANS AND PHARMACISTS 1 Tanabe , Kosuke Naomi 1 Sugimoto , Yoko 1 Fujimoto 1 Pfizer Japan Inc. Tokyo Japan INTRODUCTION and OBJECTIVE In Japan, several biosimilars have been developed and marketed from 2009. However, the degree of understanding of biosimilars among healthcare professionals is uncertain. The objective of this study was to investigate the extent of awareness and understanding of biosimilars among Japanese physicians and pharmacists. METHODS Of physicians who participated in the screening, about 35% have never heard the word of biosimilars, whereas 96% of pharmacists were aware of biosimilars (data not shown). Amongst eligible physicians, 35% of rheumatologists and 43% of oncologists had little or no idea of biosimilars. One hundred rheumatologists, 120 oncologists and 90 pharmacists who met the criteria and were aware of biosimilars were analyzed for a further questionnaire. 82% of rheumatologists and of 73% oncologists recognized that biosimilars "are relatively less expensive" and 62% of physicians simply answered "subsequent product/generic". This was a non-interventional, non-product specific, one time web-based survey conducted in May 2015. Japanese physicians for oncology and inflammation disease area and pharmacists who are involved in the formulary decision making for any biologics voluntarily joined in this study. Eligibility criteria were as follows; Intention to prescribe biosimilars if available for RA/Cancer treatment 0% Rheumatologists 1. See an average of 30 or more Rheumatoid Arthritis (RA) patients on medication per month 2. Have prescribed biologics to more than one patient with RA 3. Have ever prescribed infliximab and/or adalimumab Oncologists 1. See 30 or more patients with cancer per year of their specialties (malignant lymphoma, colorectal cancer, breast cancer and lung cancer) 2. Have prescribed biologics to more than one patient with cancer 3. Have ever prescribed rituximab, bevacizumab and/or trastuzumab Pharmacists 1. Is authorized to determine medication in the formulary at their affiliation 2. Have (had) experiences to list any biologics for RA and cancer treatment in the formulary Rheumatologists (n=100) 20% 40% 7 Oncologists (n=120) 60% 80% 51 100% 32 15 10 58 20 7 Very much willing to prescribe Willing to prescribe some, depending on products Not very much willing to prescribe Not at all willing to prescribe Reason for intention to prescribe biosimilars For screening purposes, we asked participants about their current medical care situation, the use/adoption of biologics and their awareness of biosimilars. We then gave a detailed questionnaire to the physicians/pharmacists who met the criteria described above and who answered “they were aware of biosimilars”. Questions were mainly multiple-choice (multiple answers were allowed) and for some questions, a free answer column was provided. The obtained answers were collected by attributes of subjects. Statistical analysis was not performed. Financial burden of patients may be reduced RESULTS Comparability in formulation to the reference drug is confirmed 47 56 Similarities in efficacy and safety is verified 48 55 Awareness of biosimilar among physicians and pharmacists 0% Rheumatologists 20% (n=121) HP# 40% 22 (n=61) 60% 80% 42 20 39 0 10 GP (n=60) Oncologists (n=155) Blood cancer (n=33) Breast cancer (n=40) Lung cancer Gastrointestinal cancer Pharmacists 45 23 12 25 26 (n=40) 15 43 28 45 (n=114) 0 18 6 2 #Medical institutions with 100 beds or more, and university hospitals §Medical institutions with 99 beds or less Background of physicians eligible for the questionnaire Rheumatologists N=100 Age of physician 20s 30s 40s 50s More than 60 Numbers of patients with rheumatoid arthritis† Numbers of patients treated with biologics† 1 13 25 46 15 HP# N=50 (1%) (13%) (25%) (46%) (15%) 1 13 17 15 4 96.7 24.9 (26%) Pegol Blood cancer N=30 84.6 31.6 (29%) Percentage of prescription of biologics‡ Etanercept 88% Tocilizumab 78% Infliximab 74% Adalimumab 59% Golimumab 55% Abatacept 54% Certolizumab 38% Age of physician 20s 30s 40s 50s More than 60 Numbers of cancer patients¶ 0 0 8 (16%) 31 (62%) 11 (22%) 108.9 Malignant lymphoma: 50.9 Multiple myeloma: 18.0 Acute leukemia: 17.1 Chronic leukemia: 15.1 18.3 (22%) 94% 86% 80% 60% 58% 62% 52% % 80 0 10 20 30 40 50 60 70 80 % 70 80 % 53 Oncologists (n=32) 20 30 40 50 60 70 % 80 0 10 20 30 40 50 60 71 78 48 56 52 50 48 50 58% of rheumatologists showed an intention to prescribe future biosimilars, whereas 73% of oncologists showed prescription intention. The main reason behind this was "reduction of burden on patients", followed by "confirmed similarity in efficacy/safety". Physicians with little intention to prescribe biosimilars showed strong concerns for similarity to the innovator and insufficient clinical data in efficacy/safety perspectives. Oncologists N=120 GP§ N=50 (2%) (26%) (34%) (30%) (8%) 10 Unclear whether clinical study data are sufficient 47 Have a detailed understanding of them Have heard of, and understand them to some degree Have heard of, but don't know what they are Never heard of biosimilar 70 Rheumatologists (n=42) Concerned about unexpected side effects 21 28 60 49 Concerned about efficacy which has not been evaluated in clinical trials 18 40 28 50 Concerned about comparability in formulation to reference drug 15 45 15 (n=42) 10 28 39 40 33 Unwilling 8 20 35 30 9 33 25 20 71 0 § Oncologists (n=88) Rheumatologists (n=58) Contributes to the effort to reduce medical costs in Japan 100% 26 Willing 82% 70% 68% 58% 52% 46% 24% 3 24 40 47 6 Breast cancer N=30 (3%) (20%) (33%) (39%) (5%) Lung Gastrointes cancer tinal cancer N=30 N=30 Breast cancer: 163.4 NSCLC: 75.8 Gastric cancer: 29.6 SCLC: 15.7 Colorectal cancer: 28.3 number of patients in the recent 1 month. ‡The percentage of physicians prescribed biologics in the past one year. #Medical institutions with 100 beds or more, and university hospitals. §Medical institutions with 99 beds or less. ¶The number of patients in the past 1 year. (5) (4) very important (3) (2) Rheumatologists (n=100) (1) not important 0% Chemical structure Pharmacological activity 20% 40% 26 60% 31 31 Immunogenicity Pancreatic cancer: 7.3 Percentage of prescription biologics‡ Rituximab Trastuzumab Bevacizumab Pertuzumab Trastuzumab Emtansine Cetuximab Panitumumab Mogamulizumab Brentuximab Vedotin Gemtuzumab Ozogamicin Ofatumumab (6) Oncologists (n=120) 80% 100% 32 6 41 0% 20% 23 40% 60% 25 80% 100% 33 39 20 6 31 33 34 23 611 29 35 30 411 28 36 14 51 33 30 311 30 321 Liver cancer: 14.0 Esophageal cancer: 6.4 Biliary cancer: 4.2 †The Degree of importance among biosimilar development pathway 100% 57% 50% 40% 20% 93% 87% 60% 50% - 93% - Medicinal additives Non-clinical study 60% 67% 33% 33% - Clinical pharmacokinetics Efficacy in clinical studies Safety in clinical studies 35 28 36 20 28 32 34 40 48 52 13 41 19 35 35 81 11 22 23 26 42 8 21 18 3 4 38 31 621 13 4 53 31 13 31 9 4 54 32 13 11 Characteristics of biosimilar recognized by physicians and pharmacists Rheumatologists (n=100) 0 20 Succeeding drugs which patent has expired Produced by a different manufacturer Not identical to reference biologics Investigate pharmacokinetic comparability in clinical study 60 100 0 80 20 (%) 40 60 50 100 0 20 (%) 40 41 42 40 42 (%) 67 40 82 2 In the development of biosimilars, biosimilarity between biosimilars and reference products should be evaluated based on the data from nonclinical and clinical studies in addition to the data of quality characteristics (“totality of the evidence”). However, similarities in clinical efficacy/safety were emphasized significantly and physicians recognized structural and functional similarities were relatively less important in biosimilar development pathway. CONCLUSIONS 58 73 3 100 67 39 82 80 58 47 42 60 61 52 49 0 80 62 62 Investigate the similarity of efficacy and safety to reference drug in clinical studies Same indications with reference drug can be extrapolated Cheaper than the price of reference drug None of the above (don’t know). 40 Pharmacists (n=90) Oncologists (n=120) Awareness and understanding of biosimilars amongst Japanese physicians was still low with a strong leaning toward burden on patients and sufficient clinical data to confirm biosimilarity. Although most of pharmacists were aware of biosimilars, their understanding was not enough. Providing learning opportunities for general tenets of biosimilarity and its development pathways are vital to increase social awareness and the right understanding of biosimilars. This study has several limitations on research methods as follows; subject population may be biased since this is the voluntary based survey; and relatively small sample size in oncology physicians may have issues in generalizability. ISPOR 18th Annual European Congress, Milan, 7-11 November 2015