michael reilly toronto nov19presentation final
TRANSCRIPT
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
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.
2
STEERING COMMITTEE
“The Four Pillars”
PRIORITIZING PATIENT ���SAFETY
LEVERAGING WHAT WE HAVE
LEARNED
PROMOTING PHARMACO-VIGILANCE
KEEPING ���HEALTHCARE PROVIDERS RELEVANT
ASBM’S GUIDING PRINCIPLES
4
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
Biosimilars/SEBs: A Medical Innova9on
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
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)
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.
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
11
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
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.
PHYSICIAN SURVEY FINDINGS
14
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.
15
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.
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.
Pharmacy-‐Level Subs9tu9on: A Global Challenge
How Important is No9fica9on of a Biosimilar Subs9tu9on?
18
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”
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.
Transparency in Labeling: An Emerging Issue
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”
22
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
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
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.
Thank You For Your Apen9on