Download A WEB-BASED SURVEY TO INVESTIGATE THE EXTENT OF

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