Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #2 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.

1. About Biosimilars:
What we know and what we want to
know
SAVE YOUR SKIN FOUNDATION WEBINAR
JANUARY 19, 2018
HELEN MAI, LL.B
POLICY AND STRATEGY ADVISOR, CADTH

2. Outline
1. Public Reimbursement Pathway for Biosimilars
2. Top of Mind Questions about Biosimilars
a) What is switching?
b) How are studies selected for a particular condition?
c) What are patients saying?
d) Are biosimilars all about cost savings?
e) Is Canada unique?
3. Potential Biosimilars for Cancer Indications
1

3. Public Reimbursement Pathway for
Biosimilars: Where does CADTH fit in?
Health Canada
Regulator
(Efficacy
& safety)
Pan Canadian Pharmaceutical
Alliance (pCPA)
Value
negotiator
F/P/T Ministries of Health and
Cancer Agencies
Decision
maker/
funder
CDR
(CADTH)
pCODR
(CADTH)
Quebec
(INESSS)
HTA
(Assess
value)
2

4. Public Reimbursement Pathway for
Biosimilars: Review Processes
3
Assessment: Quality,
safety, and efficacy
Output: Issuance of
NOC / NOC(c)
Assessment: Clinical
effectiveness, cost
effectiveness, patient
input, clinician input,
jurisdictional input
(pCODR)
Output: Biosimilar
Summary Dossier
Assessment: value
negotiation (through
the pCPA office),
implementation
considerations,
budget impact
analysis, may review
products individually
Output: Final funding
decision
CADTHHealth Canada Public Payers

5. Streamlining CADTH’s Biosimilars
Process
Objective
• To reduce duplication of work, optimize resources, and
ensure that all participating jurisdictions benefit from a
single approach to evidence review, which in turn would
facilitate decision-making for biosimilars
Purpose
• A streamlined approach for biosimilar reviews would
support improved access for patients
4

6. Revisions to CADTH’s Biosimilar
Process
Key Process Highlights:
• Reduce timelines
• Opportunity for stakeholder input
• Patient Groups
• Registered Clinicians
• Public Drug Programs and Cancer Agencies
• Transparency – information will be made publicly available
5

7. CADTH CDR Biosimilar Review Experience
Inflectra Grastofil Basaglar Erelzi
Brenzys
Inflectra2
July
2017
October
2016
October
2016
April
2016
March
2016
December
2014
Notes:
1. Predated current CADTH review process for biosimilars
2. Submitted for IBD indications
3. Brand Name To Be Confirmed
Omnitrope1
2009
Infliximab
Biosimilar3
Under
Review

8. Top of Mind Questions about Biosimilars
7
a) What is
switching?
b) How are studies
selected for a
particular
condition?
e) Is
Canada
unique?
c) What are
patients
saying?
d) Are
biosimilars all
about cost
savings?

9. a) What is switching?
8
Term
Interchangeability Drug plan decision (automatic substitution)
Substitution Dispensing (automatic vs therapeutic)
Switching Patient and provider decision

10. b) How are studies selected for a
particular condition?
9
Authorization of Indications
• Health Canada’s guidance:
 “Where similarity has been established, indications may be granted
even if clinical studies are not conducted in each indication. A
detailed rationale that scientifically justifies authorization of the
biosimilar in each indication should be provided taking into
consideration mechanism(s) of action, pathophysiological
mechanism(s) of the disease(s) or conditions involved, safety
profile, dosage regimen, clinical experience with the reference
biologic drug, and any case-by-case considerations. Certain
situations may warrant additional clinical data for a particular
indication.”
• Comparative clinical safety and efficacy trial is to be completed in
the most sensitive population

11. b) How are studies selected for a
particular condition?
10
- Example: Remicade and Inflectra
- Reference product: Remicade
- Indications: ankylosing spondylitis, rheumatoid arthritis,
psoriatic arthritis, plaque psoriasis, Crohn disease,
fistulizing Crohn disease, and ulcerative colitis
- Biosimilar: Inflectra
- Indications (NOC January 2014): ankylosing spondylitis,
rheumatoid arthritis, psoriatic arthritis, plaque psoriasis
- Indications (NOC June 2016): Crohn disease, fistulizing
Crohn disease, and ulcerative colitis
Note: EMA approved Inflectra for all indications, including IBD
via extrapolation in 2013 / FDA approved Inflectra for all
indications, including IBD via extrapolation in April 2016.

12. c) What are patients saying?
11
• CDR Submissions (Grastofil, Inflectra, Basaglar,
Inflectra IBD, Brenzys, Erelzi)
• Access and cost
• Safe and efficacious / Regulation / Surveillance
• Switching / Substitution
• Patient Support Programs

13. d) Are biosimilars all about cost savings?
12
• Health Canada – does not assess cost and affordability
• CADTH – drug cost comparison to reference product
• CDR reviews (based on Ontario’s transparent price)
• Grastofil: 25% less than Neupogen (filgrastim)
• Inflectra: 34% less than Remicade (infliximab)
• Basaglar: 15% less than Lantus (insulin glargine)
• Inflectra IBD: 47% less than Remicade (infliximab)
• Brenzys: 25% less than Enbrel (etanercept)
• Drug formularies – limited budgets
• Patients – greater access and affordability
• Providers – stewards of the healthcare system

14. e) Is Canada unique?
13

15. Potential Biosimilars for Cancer Indications
• Bevacizumab (metastatic colorectal cancer)
 Patent Expiry Date: 2018-04-03
• Panitumumab (metastatic colorectal cancer)
 Patent Expiry Date: 2018-05-05
• Trastuzumab (breast cancer, gastric cancer)
 Patent Expiry Date: 2018-12-10
• Rituximab (Non-Hodgkin lymphoma, chronic
lymphocytic leukemia)
 Patent Expiry Date: 2019-08-11
*Source: Health Canada’s Patent Register
1
4

16. Thank You
15

17. 16
@CADTH_ACMTS linkedin.com/company/cadth
slideshare.net/CADTH-ACMTS youtube.com/CADTHACMTS
cadth.ca/photoblog requests@cadth.ca
Connect With Us