21. Maurice Mayrides - Esperantra

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Wednesday, 20 November, 2013
Latin America Biotherapeutic Conference Day 2

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21. Maurice Mayrides - Esperantra

  1. 1. A Patient-based Perspective on the Regulation of Biosimilars Maurice (Mo) Mayrides Director, Policy and Programs Esperantra IFPMA Congreso Latinoamericano sobre Medicamentos Bioterapéuticos 19-20 November 2013 Lima, Peru
  2. 2. Esperantra We are a patient-based advocacy organization working on behalf of cancer patients in Peru since 2005. Much of our work is dedicated to coalition- and alliance-building in Peru, in Latin America, and globally International Alliance of Patients´ Organizations A global voice for patients 2
  3. 3. Importance of the Patient Voice  Patient groups have not had many opportunities to participate in these kinds of regional and international consensus meetings  We have been passive listeners mostly because it is difficult to convey and difficult for a lay audience to understand many of the technical concepts that are at the heart of this issue  But patient advocates are generally good at one thing, which is helping to tell the story of why a policy issue matters, whether this be to legislators, health authorities, or to the general public through the media  On biologics/biosimilars, the “story” we would like to be able to tell, or to help you the expert stakeholders better tell, is the following… 3
  4. 4. Full Potential of Biosimilars  Clinical enthusiasm not only for more options, but more good options, to aid in the practice of medicine  Industry enthusiasm  For new business models working in collaborative (but still contractual) scenarios where more and more companies across the globe are involved in interesting arrangements to bring biosimilars to market  Where because of competition, established pharmaceutical companies have accelerated discovery and development programs for new biologics  Government enthusiasm not only for cost savings, but an opportunity for NRAs and their corresponding MoHs to build capacity and have greater influence over health system improvements  Patient enthusiasm because all of this translates into INNOVATION  Pushing the frontiers of science and medicine  Accelerating technological advances  Moving us all closer to delivering on the promise of personalized medicine 4
  5. 5. Full Potential of Biosimilars However, we cannot tell this great story of global INNOVATION fully without: INTERCHANGEABILITY “Interchangeability and substitution are likely to be game-changers” – IMS Health “introduction and proliferation of biosimilars in the global market strongly depends on supporting legal and regulatory frameworks settled in each country, which must ensure safety, efficacy, quality and hence interchangeability” – R. Ibarra-Cabrera etal., Biotechnol Adv. 2013 May 25 5
  6. 6. How do we get to Interchangeability?  Sophisticated regulations, harmonized among countries  But why has this been so difficult?  Especially when mechanisms (both official and unofficial) for harmonization and international consensus exist and have been active  Because the value proposition of biosimilars differs by type of country  Geo-politics and the world we live in  Geo-politics doesn’t in itself have the answers, but using it as a lens for analysis can help identify the current status and look for solutions to bridge gaps  Mature economies  Emerging markets  Lower-resource settings 6
  7. 7. Mature Economies Value proposition of biosimilars is to control spiraling healthcare costs due mostly to aging populations, but without compromising quality care  Substitution not allowed and interchangeability generally not recommended as policy  National (or regional in the case of the EU) decision-making on this is delegated to provinces/states (countries for the EU), and then on to treating MDs  US FDA is an exception, but even then the decision is at the state level, and many states are considering amendments to make it an MD issue too Patients should be relatively comfortable with this…local authorities have the capacity to regulate, we trust physicians highly, and over time we can reasonably expect interchangeability will exist in the practice of medicine 7
  8. 8. Emerging Markets Value proposition of biosimilars is to broaden access to biotherapeutics, but also as an important economic growth driver because of industrial policy favoring local national production  Dual pathway and/or openness by NRAs to case-by-case consideration does not inspire confidence among patients that interpretations will not be based on things other than safety, efficacy, and quality  For example, how well-characterized are reference molecules elsewhere  Having regulations in place is in many respects the beginning, not the end, of the issue Patients should be cautiously optimistic…having regulations in place has taken considerable time and should be congratulated, but we will need real-time data to show these systems are working 8
  9. 9. Lower-resource Settings Value proposition of biosimilars is to increase affordability and public sector access to biotherapeutics, in the context of stillexisting dual burden of disease (NCDs + transmissibles)  Where draft rules exist, they are characterized by reaching minimum sufficiency to claim alignment with the WHO guidelines  Continued risk of entry of bio-copies through older rules, compromising the entire modernization exercise  Surveillance systems are not robust, so success of risk management and pharmacovigilance plans remains suspect Patients should be outright cautious…interchangeability is still far from possible 9
  10. 10. Potential Framework for Patient Advocacy This geo-political analysis can lead to ideas for what patientbased organizations might want to ask for in order to get to interchangeability Mature Economies  Clinicians can be encouraged to consider interchangeability, per local and national rules, of course, and always in the best interest of the patient  Patients generally prefer to stay on the same medicine, but we need to start gathering real-world data and experience at the clinical level  We need to continue to try to work through the technical and ethical issues raised by possible cross-over clinical trials 10
  11. 11. Potential Framework for Patient Advocacy This geo-political analysis can lead to ideas for what patientbased organizations might want to ask for in order to get to interchangeability Emerging Markets  Insist that NRAs and corresponding MoHs keep the doors open on established rules to consider—in a proactive manner—refinements to the regulations as necessary  Transparency in how the rules are being implemented  Surveillance data-sharing to show public health is protected  Continued openness to international consensus on the development of product-specific guidance 11
  12. 12. Potential Framework for Patient Advocacy This geo-political analysis can lead to ideas for what patientbased organizations might want to ask for in order to get to interchangeability Lower-resource Settings  Insist there is a very important timing issue here and draft rules need to make it to the implementation stage  Insist draft rules incorporate suggested changes based on international consensus, and that NRAs take a step back and read the final draft not with a checklist mentality, but with the overall “spirit” of the WHO guidelines in mind  Continue to build surveillance capacity, but do not over-rely on postmarketing pharmacovigilance to prove similarity after-the-fact 12
  13. 13. Conclusions  Patient advocates are important in that we can help “paint the picture” for health decision-makers of the world we want to live in  This world, already half-built, is characterized by ENTHUSIASM among all sectors and stakeholders around biosimilars  Interchangeability is the “game-changer” will allow for the full potential of biosimilars to be realized  Using the geo-political lens allows us to identify opportunities and gaps, and to build a framework for patient advocacy  Patient advocacy organizations in Latin America look forward to working more closely with you the technical experts to further build this framework 13
  14. 14. Conclusions All of this needs to keep moving forward, always with the foremost consideration that patients now and in the future deserve the best chance to access quality products and quality care, which for them means continued survival, freedom from significant disease morbidity, and potential cures. 14
  15. 15. Maurice (Mo) Mayrides Teléfono: +51 (1) 2215518 Cel. +51 994681819 mmayrides@esperantra.org 15

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