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Biosimilars Presentation - Save Your Skin Foundation


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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.

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Biosimilars Presentation - Save Your Skin Foundation

  1. 1. Issues with Biologics and Biosimilars for Oncology Patients Louise Binder Health Policy Consultant Save Your Skin Foundation January 19, 2018
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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: radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html CADTH • Biosimilar Drugs: Health care provider hand-out • Biosimilar Drugs: Patient hand-out Available at: Biosim•Exchange • Biosimilars Facts Available at: