Physician Perspectives on Subsequent Entry Biologics (SEBs)
Michael S. Reilly, Esq.Executive Director, Alliance for Safe Biologic Medicines
March 31, 2015
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About ASBM
The Alliance for Safe Biologic Medicines
• 2010 ASBM formed to provide STAKEHOLDER GUIDANCE on SEBs/biosimilars to regulators worldwide
• MEMBERS: consist primarily of physician and patient groups, EuropaBio, and BIOTECanada.
• ADVISORY BOARD: Composed of Physicians, Researchers, Pharmacists, and Patients from around the world. Serves as resource on the science and clinical use of SEBs/biosimilars, guides our policy recommendations
• Learn more at www.safebiologics.org 33
STEERING COMMITTEE
“The Four Pillars”
PRIORITIZING PATIENT SAFETY
LEVERAGING WHAT WE
HAVE LEARNED
PROMOTING PHARMACO-VIGILANCE
KEEPING DOCTORS RELEVANT
ASBM’S GUIDING PRINCIPLES
ASBM Physician Surveys
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U.S. Physician Survey (September 2012)• 376 physicians
E.U. Physician Survey (November 2013)• 470 physicians• Subject of June 2014 research paper in the
Journal of the Generics and Biosimilars Initiative (GaBI Journal)
Canadian Physician Survey (November 2014)• 427 physicians
U.S. Labeling Survey (February 2015) • 400 physicians
To learn more about ASBM surveys, visit www.SafeBiologics.org
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Canadian Physician Survey
Industry Standard Research 7
Survey Objectives
Provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding subsequent entry biologics (SEBs), particularly in regard to SEB naming:
• Measure physician familiarity and understanding of SEBs
• Assess the implications of an SEB sharing a nonproprietary name with its reference innovator product
• Determine how physicians identify biologics in patient records and in adverse event reporting
• Gather physician perspective on the importance of distinguishable naming
Industry Standard Research 8
About the Survey
• 427 Prescribers were recruited from 4 provinces in Canada– Alberta– British Columbia– Ontario– Quebec
Ontario; 51%
Quebec; 22%
B.C.; 15%
Alberta; 12%
Industry Standard Research 9
Allergy / Immunology
Infectious Diseases
Endocrinology
Nephrology
Urology
Neurology
Rheumatology
Respiratory / Pulmonology
Oncology
Gastrointestinal
Internal Medicine
Dermatology
4%
4%
5%
6%
6%
8%
8%
9%
10%
12%
13%
14%
Respondents: Primary Therapeutic Area“Please indicate your primary practice area or therapeutic area in which you practice?” (N=427)
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Other
Multi-specialty clinic
Private, family practice
Hospital
Academic medical center
Community setting
1%
7%
7%
17%
33%
35%
“Which of the following best describes the type of practice in which you work?” (N=427)
Respondents: Practice Setting
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More than 30 years
21-30 years
11-20 years
6-10 years
1-5 years
11%
29%
35%
16%
8%
Length of Time in Healthcare Sector
“How long have you been in medical practice?” (N=427)
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Physician Knowledge of SEBs
Industry Standard Research 13
Have never heard of them
I've heard of them but could not define them
Familiar, have a basic understanding of them
Very familiar, I have a complete understanding of them
10%
31%
48%
10%
Familiarity with SEBs“How familiar are you with subsequent entry biologic (biosimilars) medicines?” (N=427)
Industry Standard Research 14
Comparison: Percentage of Physicians who Haven’t Heard of Biosimilars/SEBs or Could Not Define
CAN US EU
41%
22%24%
Industry Standard Research 15
53%
47%
Yes No
Indication Extrapolation
“Are you aware that a subsequent entry biologic may be approved for several or all indications of the reference product on the basis of clinical trials in only one of those indications?” (N=427)
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Naming of SEBs
Industry Standard Research 17
Nonproprietary Name Implications: Structurally Identical?
64%
30%
6%
Yes No No Opinion
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that the medicines are structurally identical?” (N=427)
Industry Standard Research 18
Comparison: Does Same INN=Structurally Identical?
CAN US EU
64%
76%
53%
30%
14%
32%
6%10%
15%
YESNO NO OPINION
Industry Standard Research 19
62%
33%
6%
Yes No No Opinion
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that a patient could receive either biologic product and expect the same result?” (N=427)
Nonproprietary Name Implications: Same Results?
Industry Standard Research 20
49%
40%
11%
Yes No No Opinion
Nonproprietary Name Implications: Substitution During Course of Treatment
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that a patient could be safely switched from a reference biological medicine to its SEB during a course of treatment and expect the same result with either of the products?” (N=427)
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76%
19%
5%
Yes No No Opinion
Nonproprietary Name Implications: Approved for Same Indications?
“If two biologic medicines have the same non-proprietary / generic name, does this suggest to you the medicines are approved for the same indications?” (N=427)
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Identification of Biologic Medicines
Industry Standard Research 23
Other
DIN number
Non-proprietary / Generic name
Product name / Brand name
1%
0%
17%
82%
Biologic Recording – Patient Record“When you identify the prescription of a biologics drug in your patient record, are you likely to identify the medicine by:” (N=427)
Industry Standard Research 24
Biologic Recording – Adverse Events“Physicians play an important role in the identification and reporting of unexpected or serious adverse events to Health Canada and manufacturers. In the context of identifying a biologic for purposes of reporting an adverse event, how do you identify the medicine?” (N=427)
Other
DIN number
Non-proprietary name / Generic name
Product name / Brand name
1%
3%
26%
70%
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Comparison: Percentage of Prescribers using INN ONLY when Reporting Adverse Events.
CAN EU
26%
17%
Industry Standard Research 26
26%
29%
45%
Always Sometimes Never
“How often do you include the batch number when reporting adverse events?” (N=427)
Batch Number Inclusion
Industry Standard Research 27
Reason for Not Including Batch Number
“What are the main reasons for not reporting the batch number?” (N=317)
Other
Form / System does not have dedicated field
Forget to include this information
Not sure where to find this information
Do not have it available at the time of reporting
4%
3%
15%
29%
50%
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Distinguishable Naming
Industry Standard Research 29
79%
8%
13%
Yes No No Opinion
Distinct Nonproprietary Names“In your opinion, should Health Canada insist on a distinct non-proprietary / generic name for every biologic or SEB product approved by them?” (N=427)
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Other (Please specify)
The same INN as the innovator product with a code identifying the manufacturer
The same INN as the innovator product with a differentiating suffix
The same INN as the innovator product with a differentiating prefix
A completely different INN for SEB/biosimilar and reference product
0%
9%
11%
26%
54%
Differentiating SEBs from Innovator Products
“What is the best way for Health Canada to differentiate a SEB from the innovator biologic?” (N=427)
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What We Learned
The survey identifies a need for additional education and information on SEBs among Canadian physicians.
Misconceptions about SEBs, along with physician prescribing and recording practices, highlight the need for a distinguishable naming scheme for all biologics, including SEBs.
Physicians overwhelmingly (79%) supported Health Canada implementing distinguishable names, with the majority (54%) identifying unique nonproprietary names as their preferred method.
Thank You For Your Attention