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)

Industry Standard Research 10

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

Industry Standard Research 11

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%

Industry Standard Research 25

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)

Industry Standard Research 30

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