Michael reilly toronto nov19presentation final
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Transcript of Michael reilly toronto nov19presentation final
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Biosimilars/Subsequent Entry Biologics: Innova9ons and Challenges
Michael S. Reilly, Esq. Executive Director, Alliance for Safe Biologic Medicines
Presented at the Expert Patient Advocates & 21st Century Therapies Forum November 19, 2015
Toronto, ON
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About The Alliance for Safe Biologic Medicines (ASBM)
Harry L. Gewanter, MD, FAAP, FACR: Chairman, pediatric rheumatologist
Philip Schneider: Dean, University of Arizona College of Pharmacy-‐ Advisory Board Chair Michael Reilly, ExecuJve Director [email protected]
• Steering CommiMee composed of paJent and physician groups.
• Advisory Board of physicians, researchers, pharmacists, and paJents.
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STEERING COMMITTEE
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“The Four Pillars”
PRIORITIZING PATIENT ���SAFETY
LEVERAGING WHAT WE HAVE
LEARNED
PROMOTING PHARMACO-VIGILANCE
KEEPING ���HEALTHCARE PROVIDERS RELEVANT
ASBM’S GUIDING PRINCIPLES
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Biologic vs. Chemical Medicines SIZE: significantly larger, potenJal for immunogenic reacJons
STRUCTURE: more complex, cannot be completely characterized or copied
STABILITY: suscepJble to light, heat, denaturing / degradaJon
SENSITIVITY: even small manufacturing changes can cause changes in efficacy and/or adverse effects
DRIFT: can change with Jme
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Biosimilars/SEBs: A Medical Innova9on
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Benefits of Biosimilars/SEBs for Pa9ents
• Increased therapeuJc opJons
– More treatment choices for physician and paJent.
• Cost savings over reference biologics:
– Unlike generics, which save 40-‐80%, due to higher development costs biosimilars are expected to save payers 15-‐30%1
1. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. DOI: 10.5639/gabij.2012.0103-4.036
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Challenges of Bringing Biosimilars to Pa9ents
• FDA’s Dr. Janet Woodcock, spoke this week regarding the challenges of introducing biosimilars, saying: "There will be a phase [in] of acceptance, or perhaps, partly rejec9on, from the medical community,”
• Success will be related to the degree of physician comfort with biosimilars.
Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the U.S. (FDA)
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Building Physician Confidence
• ASBM has engaged with the physician community through surveys and ConJnuing EducaJon courses.
• Goal: to build physician confidence in biosimilars, so that physicians can confidently prescribe, or switch paJents to biosimilars.
• However, recogniJon of the differences between biosimilars and generics have resulted in physician cauJon regarding biosimilar adopJon.
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Gathering the Perspec9ves of Biologic Prescribers Around the World
U.S. Physician Surveys (September 2012): 376 physicians (February 2015): 400 physicians (Labeling) (November 2015*): 400 physicians
E.U. (France, Italy, Spain, UK) Physician Survey (November 2013): 470 physicians
Canadian Physician Survey (December 2014): 427 physicians
U.S. Pharmacist Survey (September 2015) 401 pharmacists
La9n America (Argen9na, Brazil, Colombia, Mexico) Physician Survey (May 2015): 399 physicians
All surveys available at www.SafeBiologics.org
*Tena9ve release date
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November 2014: Presented European Survey Data to Spanish Health Ministry December 2014: Presented Canadian Physician Survey data to Health Canada
May 19, 2015: Shared U.S. data and recommendaJons with U.S. Dept. of Health and Human Services and other AdministraJon officials April 13, 2015: ParJcipated in 60th WHO ConsultaJon on InternaJonal Nonproprietary Names (INN)
June 2015: ParJcipated in WHO Frontpage MeeJng to finalize the Biologic Qualifier (BQ) proposal.
October 13: ParJcipated in the 61th WHO INN ConsultaJon
October 14: Presented LaJn American survey data at BIO LaJn America Conference in Brazil
Recent ASBM AcCvity Sharing Findings with Na9onal and Interna9onal Regulators
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Issues Regulators Need to Address • Assess need for clinical data, as it relates to approval and
indicaJon extrapolaJon.
• What data do physicians want to see in order to feel comfortable prescribing? – Physicians want informaJon not only on adverse events,
but data which demonstrate successful clinical use of biosimilars (post-‐market data)
• Assurance of transparency, in naming and labeling-‐ what the product is and how it became approved.
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PHYSICIAN SURVEY FINDINGS
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Indica9on Extrapola9on: A Key Concern
80% of physicians considered it important for label to show whether approval for an indicaJon was based on DATA or EXTRAPOLATION:
• ExtrapolaJon remains a concern for physicians and paJent groups.
• Both want some assurances that clinical data used for one disease area can be applied to demonstrate efficacy in another.
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Recent ASBM AcCvity Timeline: Biologic Naming • July 2014: WHO Proposes its “Biological
Qualifier”-‐ a 4-‐leMer code to disJnguish similar biologics from each other. www.who.int
• August 2015: U.S. Food and Drug AdministraJon (FDA) issues Guidance supporJve of and compaJble with WHO’s BQ. www.fda.gov
• Both call for similar biologics (including biosimilars) to have a shared root name (InternaJonal Nonproprietary Name/ INN) followed by a four-‐leMer suffix.
• Health Canada has been generally supporJve of the WHO approach.
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Widespread Physician Support for Dis9nguishable Naming
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94% of La9n American Physicians consider WHO’s BQ Proposal to be “useful” in helping pa9ents receive the correct medicine.
79% of Canadian physicians support Health Canada issuing dis9nct names.
66% of US physicians (and 68% of US pharmacists) support FDA issuing dis9nct names.
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Pharmacy-‐Level Subs9tu9on: A Global Challenge
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How Important is No9fica9on of a Biosimilar Subs9tu9on?
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87% of La9n American Physicians consider it “very important” or “cri9cal”
85% of Canadian consider it “very important” or “cri9cal”
80% of US physicians consider it “very important” or “cri9cal”
77% of EU Physicians consider it “very important” or “cri9cal”
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Importance to Pa9ents
• PaJent always needs to be informed about the medicine he/she is receiving in order to make informed choices and be an effecJve partner in care.
• Physician needs to be aware of what medicine paJent is receiving to provide proper care.
• Accurate paJent record must be kept for pharmacovigilance/post-‐market monitoring for adverse events and efficacy
• Physicians and pharmacists have a responsibility to the paJent and to the larger community (other healthcare providers, regulators, manufacturers) to work collaboraJvely together – that includes clear, Cmely communicaCon.
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Transparency in Labeling: An Emerging Issue
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March 6: First Biosimilar Approved in U.S.
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Reference ID: 3711895
• Zarxio (filgras9m-‐sndz)
• Went on sale September 3.
• 15% discount over reference product
• Not “interchangeable”
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Concerns Surrounding Biosimilar Labeling Some concerns surrounding insufficient transparency in Zarxio’s labeling:
• It is not idenJfied as a biosimilar.
• No data used to demonstrate biosimilarity is included.
• Not specified for which indicaJons approval was based on trial data, or extrapolaJon.
• Data from innovator product is not idenJfied as such.
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Reference ID: 3711895
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What Do Physicians Want to See on a Biosimilar Label?
23
These items were consistently rated a “4” or a “5”-‐ indicaJng high or very high importance in a February 2015 Survey of 400 U.S. physicians: 90% -‐ That product is a biosimilar 79% -‐ A definiJon of biosimilarity 82% -‐ AnalyJcal data used by biosimilar sponsor to demonstrate its similarity to its reference product 83% -‐ Clinical data used to demonstrate biosimilar is highly similar to reference product 79% -‐ Post-‐market surveillance data on the biosimilar 77% -‐ Name of the biosimilar's reference product 79% -‐ IndicaJons for which the originator is approved, but the biosimilar is not 79% -‐ Clear disJnguishable reference product data from biosimilar data 79% -‐ Clinical similarity data including immunogenicity effects 80% -‐ Which approved indicaJons were actually studied, vs. which were extrapolated from data in other indicaJons? 79% -‐ Whether or not the biosimilar is "interchangeable" with its reference product
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Summary
24
• Building physician confidence is essenJal in order to bring the innovaJons of biosimilars to paJents.
• Physicians worldwide support the use of disJnguishable names for biologic products.
• In the event of a biosimilar subsJtuJon, physicians worldwide consider it very important to know the exact medicine their paJent receives.
• Transparency in labeling also helps providers make informed decisions and promotes confidence in biosimilars. IndicaJon extrapolaJon is of parJcular concern.
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Thank You For Your Apen9on