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Biosimilars Presentation - Health Canada

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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.

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Biosimilars Presentation - Health Canada

  1. 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. 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 2
  3. 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 3
  4. 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 4
  5. 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? 5
  6. 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. 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. 7
  8. 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 8
  9. 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) 9
  10. 10. 5. What is Health Canada’s position on switching and interchangeability? 10 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. 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 11
  12. 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 12
  13. 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 13
  14. 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 14

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