Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #1 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
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada

2. Outline
• What are biologics and biosimilars ?
• How are biosimilars regulated by Health Canada?
• Questions about biosimilars from a regulator’s perspective
• What’s Next?
– Key Health Canada activities related to biosimilars
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3. What are biologics and biosimilars?
Biologic drugs
• Derived from metabolic activity of living organisms.
• Large, structurally complex and difficult to characterize , and inherently more
variable
• Sensitive to light, temperature and susceptible to contamination
• Differences between small molecule drugs and biologics require differences in
regulatory requirements – strong regulatory oversight
Biosimilars
• A biosimilar is a biologic drug that enters the market subsequent to a version
previously authorized in Canada, and has demonstrated similarity to a reference
biologic drug (originator)
• The demonstration of similarity enables the sponsor to rely on relevant publicly
available information (safety and efficacy) about the reference biologic drug
• Submissions currently under review for oncology biosimilars for TRASTUZUMAB ,
RITUXIMAB, BEVACIZUMAB
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4. How are biosimilars regulated by Health Canada?
• Biosimilars are regulated as new drugs in Canada; they are subject to
the Food and Drugs Act and the Food and Drug Regulations just like
other new biologic drugs
• Flexibility under existing framework allows for the regulation of
biosimilars using the concept of similarity
• The same regulatory controls and post-market surveillance
requirements apply
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5. Questions about biosimilars from a
regulatory perspective
1. How do the development
and regulatory review
processes for innovators and
biosimilars differ?
2. Why are “traditional” clinical
studies not needed in each
indication?
3. Are biosimilars as safe and
effective as the originator
products?
4. How does Health Canada
align internationally?
5. What is Health Canada’s
position on switching and
interchangeability?
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6. 1. How do the development and regulatory review
processes for innovator products and biosimilars differ?
Innovator Product
-Sponsor must independently
demonstrate the quality, safety
and efficacy of a therapeutic
product.
Biosimilar
-Biosimilar sponsor must
demonstrate similarity and
that there are no clinically
meaningful differences
between the biosimilar and
innovator product
-Step-wise approach with
quality comparability as the
foundation
6Accessed at: http://www.health.gov.au

7. 2. Why are “traditional” clinical studies not required in
each indication?
 The innovator has established efficacy and safety for each indication.
 A biosimilar does not have to re-establish the de novo benefit/risk
 Since a biosimilar is very similar in structure and function to a reference biologic drug with
well-established safety and efficacy, clinical studies do not need to be repeated for each
indication.
 The purpose of the clinical program is to show that residual uncertainty from
the quality assessment does not cause clinically meaningful differences in
efficacy, safety and/or immunogenicity in a sensitive population.
 A biosimilar sponsor is eligible to apply for the indication(s) and condition(s)
of use that are held by the reference biologic drug authorized in Canada
based on the totality of evidence obtained from all comparative analyses.
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8. 3. Are biosimilars as safe & effective as the originator?
Patients can be confident that a biosimilar will work the same as
its reference drug
When Health Canada approves a biosimilar:
The quality, safety and efficacy of the biosimilar are highly similar
to the reference biologic drug
There are no clinically meaningful differences between the
biosimilar and the reference biologic drug
Patients and healthcare professionals can have the same
confidence in the quality, safety and efficacy as any other biologic
drug
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9. 4. How does Health Canada align internationally?
• Health Canada’s regulatory framework for biosimilars was largely
modelled after Europe’s framework
• Health Canada experts regularly interact with those from other
regulatory agencies – to promote regulatory alignment and
information-sharing
 Regular Biosimilar Cluster teleconferences (FDA-EMA-Japan-Canada)
 WHO – biosimilar guideline drafting groups
 International Pharmaceutical Regulators Forum (IPRF) Biosimilars Working Group
 Large group of regulatory authorities
 Health Canada has just taken on the role of co-chair of this group
 New group being formed with regulators from Australia, Canada,
Singapore, Switzerland (ACSS)
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10. 5. What is Health Canada’s position on switching and
interchangeability?
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Health Canada Europe EMA US FDA
• Health Canada's
authorization of a
biosimilar is not a
declaration of
equivalence to the
reference biologic drug
• The authority to declare
two products
interchangeable rests
with each province and
territory
• Authorization by the
EMA does not include a
recommendation on
interchangeability
• Substitution policies
vary between member
states
• Interchangeable
designation and
standards are mandated
by law
• Draft guidance
published by FDA in Jan.
2017
• No interchangeable
biosimilar products
licenced to date

11. What’s Next?
Biologics Naming
• Calls for a naming convention that distinguishes between biologic drugs that share the
same common name to facilitate accurate prescribing, dispensing and surveillance
• Differing approaches internationally
• Consultation launched January 18th to help inform development of a Canadian policy
https://www.ismp-canada.org/biosimilars/consultation.html
https://www.ismpcanada.org/fr/biologiques/consultation.html
Stakeholder outreach and education
• Health Canada is exploring a series of webinars on biosimilars
• Comments, questions, ideas are welcome
Capacity building and information sharing
• Hiring new review staff to respond to increase in number of biosimilar submissions
• Implementing tools to facilitate information-sharing with partners, such as Health
Technology Assessment Bodies
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12. Contact information:
Stephanie Hardy
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Stephanie.hardy@canada.ca
Cathy Parker
Director General
Biologics and Genetic Therapies Directorate
Cathy.parker@canada.ca
Health Canada Biosimilars webpage
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/biosimilars-biosimilaires-index-eng.php
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13. Authorized Biosimilars - as of January 2018
Biosimilar Reference
Biologic Drug
Therapeutic area Date of NOC
Omnitrope
(Somatropin – Human
Growth Hormone)
Genotropin Growth Hormone Deficiency in Children and
Adult Growth Hormone Deficiency
April 20, 2009
Omnitrope Genotropin Additional indications for Small for
Gestational Age, Idiopathic Short Stature and
Turner Syndrome
May 8, 2015
Inflectra
(Infliximab –Monoclonal
Antibody)
Remicade Rheumatoid Arthritis, Ankylosing Spondylitis,
Psoriatic Arthritis and Plaque Psoriasis
January 15, 2014
Inflectra Remicade Additional indications for Adult Crohn's
disease, including fistulising Crohn's disease
and adult ulcerative colitis
June 10, 2016
Remsima
(Infliximab – Monoclonal
Antibody)
Remicade Rheumatoid Arthritis, Ankylosing Spondylitis,
Psoriatic Arthritis and Plaque Psoriasis
January 15, 2014
Remsima Remicade Additional indications for Adult Crohn's
disease, including fistulising Crohn's disease
and adult ulcerative colitis
August 5, 2016
Basaglar
(Insulin Glargine -
Recombinant Human
Insulin Analogue)
Lantus Treatment of pediatric (>6 years) and adult
patients with Type 1 diabetes mellitus, and
adult patients with type 2 diabetes mellitus
September 1, 2015
Grastofil (filgrastim) Neupogen Prevention or treatment of neutropenia December 7, 2015
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14. Biosimilar Reference
Biologic Drug
Therapeutic area Date of NOC
Brenzys (entanercept) Enbrel Rheumatoid Arthritis and Ankylosing
Spondylitis
August 31, 2016
Erelzi (entanercept) Enbrel Rheumatoid Arthritis, Polyarticular
Juvenile Idiopathic Arthritis and
Ankylosing Spondylitis
April 6, 2017
Renflexis (Infliximab) Remicade Rheumatoid arthritis, Ankylosing
Spondylitis, Psoriatic arthritis, Plaque
Psoriasis, Adult Crohn’s disease,
including fistulising Crohn’s disease and
adult ulcerative colitis
December 1, 2017
Admelog (insulin lispro) Humalog Treatment of patients with diabetes
mellitus.
November 16, 2017
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