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

1. Issues with Biologics and Biosimilars
for Oncology Patients
Louise Binder
Health Policy Consultant
Save Your Skin Foundation
January 19, 2018
louise.binder@rogers.com

2. Safety and Efficacy of Products Originator Biologics- Recap
• Biologics are made from living cells, with large and complex molecular structures
• Biologics are much more complex than small molecules to manufacture
• Many factors in the manufacturing process influence the outcome of each batch
e.g. room temperature, water used, food used to grow cells, type of cells used to
grow the biologic
• No two batches of the same biologic are exactly the same
• Just the nature of the product – rely on manufacturers and regulators

3. Safety and Efficacy of Biosimilars - Recap
• Biosimilars are biologics that are similar to an existing originator biologic but are
not identical
• Biosimilars are legally permitted for sale with regulatory approval after the patent
for the originator biologic has expired
• The innovative clinical research to create the product is not required
• Good manufacturing practices are required

4. Are biosimilars safe and effective?
First line therapy- RECAP
• Health Canada reviews biosimilars for sale based on an analysis of whether the
product is of similar quality, safety, and efficacy to the originator biologic
• If Health Canada finds that the biosimilar is highly similar to an originator biologic
and that there are no clinically meaningful differences in safety and efficacy
between them it will approve the biosimilar for sale in Canada

5. Does this mean Biosimilars are safe and effective
in first line therapy ?
• Health Canada makes its decisions based on a robust science-based regulatory
framework that aligns closely with other regulatory
• Thus generally if Health Canada approves a biosimilar it is a good therapy e.g. first
line therapy
• As with any drug, individual response may vary so obviously every decision must
be made by the patient and the physician

6. Will the Biologic and Biosimilar be
safe and effective over time ?
• Biologics are proteins
• These proteins are created in the blood and body tissue by the immune system to
neutralize or destroy sources of disease
• This immune response is also called Immunogenicity
• Immunogenicity or immune response may change over time potentially making a
biologic or biosimilar less effective
• This is a matter for monitoring and ongoing discussion between doctor and
patient

7. What about changing from a
Biologic to a Biosimilar ?
• Interchangeability refers to situations where treatments are considered to be
equivalent and can be therefore be substituted by a pharmacist without a
physician’s consent. This is often the case with small molecule drugs where the
brand name drug is substituted for a generic.
• Health Canada states “the term interchangeability often refers to the ability for a
patient to be changed from one drug to another equivalent drug by a pharmacist,
without the intervention of a doctor who wrote the prescription.”
• Biosimilars are not deemed to be interchangeable by Health Canada

8. What is Automatic Substitution?
• Automatic Substitution refers to a situation where a prescriber
prescribes one treatment and the pharmacist filling the prescription
changes it for another equivalent drug based on his/her professional
judgment and payer reimbursement criteria. The patient must be
informed in both cases and must agree to this substitution. If the
patient refuses, he /she may well have to pay for some or all of the
treatment himself/herself.
.

9. What is switching ?
• Switching is a form of substitution that occurs when a patient on a
biologic treatment is switched during treatment to a biosimilar by a
prescriber (physician). A physician may choose to switch their patient
from an originator biologic to the biosimilar product if they think it
will be worthwhile and with patient consent, but a pharmacist may
not change the patient to a biosimilar. This should only be done with
the agreement of the patient.

10. Access and Reimbursement Issues
• Biologics are costly to manufacture
• The price for them may make it difficult for the public and even private
reimbursement systems to afford to include them for coverage
• Drug budgets generally save money by paying for biosimilars rather than
biologics
• All other relevant factors being equal e.g. safety, efficacy, adherence factors,
taking a biosimilar as first line therapy rather than a biologic may well save money
in the drug budget
• These savings should however accrue to the drug budget solely and to the
portion of the budget where the savings were gained

11. Naming of Biosimilars
• For safety reasons, it is important to be able to distinguish biologic drugs that
share the same international non-proprietary name (e.g. a biosimilar and the
originator biologic)
• Health Canada has just launched a consultation on the naming of biologics

12. Summary of Oncology Conclusions To Date
• Biosimilars are carefully reviewed by Health Canada for similar safety, quality and efficacy to the
originator biologic and are approved for sale if they demonstrate they are highly similar to the
originator biologic with no clinically meaningful differences in safety and efficacy in them
• Thus, generally for first line therapy , those biosimilars approved by Health Canada are reasonable
options for consideration in oncology subject to individual idiosyncratic medical responses. The
decision reached between the patient and physician is always paramount.
• Reimbursement for Health Canada approved oncology biosimilars will be made by public and
private payers with advice from the pan-Canadian Oncology Drug Review (pCODR) programme of
the Canadian Agency for Drugs and Technologies in Health (CADTH) and the pan-Canadian
Pharmaceutical Alliance (pCPA) where appropriate.
• Reimbursement for biosimilars may be in addition to the originator biologic or in place of the
originator biologic based on reimbursement policy
• Savings from the use of oncology biosimiliars should be credited to and remain in the oncology
drug budget
• Switching is not an issue presently in oncology as treatments are generally for a course, over a
limited period of time, rather than ongoing
• Differential naming between originator biologics and biosimilars is important to ensure that
treatments can be tracked should safety concerns arise

13. Questions ?
Cathy Parker
Director General, Biologics and Genetic Therapies Directorate
Stephanie Hardy
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Helen Mai
Policy and Strategy Advisor, CADTH
Louise Binder
Health Policy Consultant, Save Your Skin Foundation

14. Some Helpful Biosimilar Resources
Health Canada
• The Guidance Document Information and Submission Requirements for Biosimilar
Biologic Drugs
• The Fact Sheet: Biosimilar biologic drugs in Canada provides information about
biosimilars and their regulation in Canada
• Summary Basis of Decision (SBD) documents explain in further detail why Health
Canada authorized certain drugs for sale in Canada. SBD documents are available for
biosimilars authorized in Canada
Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-
radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html
CADTH
• Biosimilar Drugs: Health care provider hand-out
• Biosimilar Drugs: Patient hand-out
Available at: https://cadth.ca/biosimilar-drugs
Biosim•Exchange
• Biosimilars Facts
Available at: http://biosim.jointhealth.org/facts