subsequent entry biologics - ontario rheum · innovator biologic, following patent expiry; one that...
TRANSCRIPT
5/24/2014
1
Subsequent Entry Biologics
Saturday, 24 May 2014
Leigh Revers, M.A., D.Phil.
• The speaker has received honoraria for educational speaking activities funded by—
• Hoffmann-LaRoche
• Janssen
• AMGEN
Disclosures
5/24/2014
2
• Provide working definitions of biologics and subsequent entry biologics
• Provide a summary of biologics & SEBs currently used in rheumatology
• Highlight some current attitudes of rheumatologists to the clinical introduction of SEBs
3
Learning Objectives
4
What are biologics?
Biologics are active pharmaceutical ingredients obtained from living organisms that are not amenable to large-scale chemical synthesis.
5/24/2014
3
5
How do biologics compare to conventional small molecule drugs?
Insulin(5,808)
Aspirin(180)
Erythropoetin(30,400)
Monoclonal antibody(150,000+)
Revers, L. & Furczon, E. (2010) An introduction to biologics and
biosimilars. Part I: Biologics: What are they and where do they
come from? Can. Pharm. J. 143:134.
6
Japanese clinical trials of biologic therapies for rheumatoid arthritis
Takeuchi, T. & Kameda, H. (2010) The Japanese experience with biologic
therapies for rheumatoid arthritis Nat. Rev. Rheumatol.
doi:10.1038/nrrheum.2010.154
5/24/2014
4
7
Woodrick, R. S. & Ruderman, E. M. (2011) Safety of biologic therapy in
rheumatoid arthritis. Nature Rev. Rheumatol. 7:639.
8
What are SEBs?
A Subsequent Entry Biologic is a Canadian-approved, new version of an innovator biologic, following patent expiry; one that has undergone a rigorous comparability exercise.
5/24/2014
5
9
Biologics in rheumatology
Referencebiologic
Indication Biosimilars
RA PsA ASCanadian
patent expiry
Approved
in Canada
In
development
abatacept Y - - 2012* - -
tocilizumab Y - - 2015 - -
adalimumab Y Y Y 2017 - 13infliximab Y Y Y 2017 2 14†
rituximab Y - - 2020 - 35†
cetolizumab Y - - 2021 - -
golimumab Y Y Y 2021 - -
etanercept Y Y Y 2023 - 27†
ustekinumab - Y - Infringement - -
* Data exclusivity until 2014
† Source: FirstView Biosimilar Index, March 2014
Rader, R. A. (2013) An analysis of the US biosimilars development pipeline
and likely market evolution. BioProcess Int. 11(6s):16.
Survey Results (Run from 15 February to 16 March, 2014)
Made possibly with the support of theCanadian Rheumatology Association
Sponsored by the Institute of Management of Innovation at the University of Toronto
5/24/2014
6
11
Where do you practice?
Alberta, 11, 14%
British Columbia,
13, 16%
Manitoba, 3, 4%
Newfoundland
& Labrador,1, 1%
Nova Scotia, 3, 4%
Ontario, 36, 44%
Quebec, 12, 15%
Saskatchewan, 2, 2%
12
How familiar are you with SEBs?
15, 19%
10, 12%
32, 40%
23, 28%
1, 1%
0% 10% 20% 30% 40% 50%
Very familiar
Familiar
Somewhat familiar
Unfamiliar
Never heard of SEBs
5/24/2014
7
13
“I am generally comfortable prescribing biologic drugs to my patients.”
4%, 3 2%, 2
25%, 20
69%, 56
0
10
20
30
40
50
60
StronglyDisagree
Disagree Neutral Agree StronglyAgree
14
“SEBs will have a significant impact on rheumatology and how patients are treated.”
1%, 1
7%, 6
26%, 21
57%, 46
7%, 6
1%, 10
5
10
15
20
25
30
35
40
45
50
StronglyDisagree
Disagree Neutral Agree StronglyAgree
Abstain
5/24/2014
8
15
“If an SEB demonstrates that it is comparable to the brand-name drug, it is appropriate to offer it to a biologic-naïve patient instead of the brand-name drug.”
1%, 1
14%, 11
26%, 21
52%, 42
7%, 6
0
5
10
15
20
25
30
35
40
45
StronglyDisagree
Disagree Neutral Agree StronglyAgree
16
“If an SEB demonstrates that it is comparable to the brand-name drug, it is appropriate to switch a biologic treatment-stable patient to the SEB.”
30%, 24
37%, 30
25%, 20
7%, 6
1%, 1
0
5
10
15
20
25
30
35
StronglyDisagree
Disagree Neutral Agree StronglyAgree
Abstain
5/24/2014
9
17
“All things considered, I would feel comfortable prescribing SEBs to patients if approved today.”
10%, 8
30%, 24 30%, 2427%, 22
4%, 3
0
5
10
15
20
25
30
StronglyDisagree
Disagree Neutral Agree StronglyAgree
Thank you