Transcript Apresentação do PowerPoint

Latin American Biologics/Biosimilars Conference
Presented by the Alliance for Safe Bioloigic
Medicines & the Global Colon Cancer Association
Andrew Spiegel, Esquire
[email protected]
THANK YOU!
Introduction
Andrew Spiegel, Esq.
•
Patient Advocate since 1998
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Co-Founded the Colon Cancer Alliance
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Executive Director of the Global Colon Cancer
Association (GCCA)
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Chair, Digestive Disease National Coalition
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Board Member, International Association of Patient
Organizations (IAPO)
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Co-Founder and Steering Committee Member of the
Alliance for Safe Biologic Medicines
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The Alliance for Safe Biologic Medicines (ASBM)
ASBM is an organization consisting of patient,
physician, research and manufacturing
organizations devoted to promoting the safe
introduction and monitoring of biosimilar
medications
STEERING COMMITTEE
• Steering Committee composed of patient and
physician groups
• International Advisory Board of physicians,
researchers, pharmacists, and patients
• 66 members on 5 continents and growing
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ASBM Latin American Chapter
ASBM’s Latin American Chapter
has 8 founding members.
ASBM Member IAPO also
represents 62 Members in Latin
America and the Caribbean.
Sharing Physician Perspectives With Regulators
Europe:
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2014-2016: 58th-63rd WHO INN Consultation and Frontpage meetings
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2014: Presented European data European commission, and country-specific
survey data to Spain, Italian, Health Ministries
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2015: World Biosimilars Congress- Basel, Switzerland
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2016: Biosimilars Labeling Conference, Brussels, Belgium
North America:
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2014: Present Canadian Survey data to Health Canada
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2015: Shared U.S. data and recommendations with U.S. Dept. of Health and
Human Services and other Administration officials.
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2016: Three FDA Arthritis Advisory Committee Hearings
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Numerous U.S. State Legislatures 2010-2016
Sharing These Perspectives in Latin America
2014:
• Alanzia Latina/ IAPO Conference;
Int’l Regulator Conference (Pre-ICDRA) - Rio de Janeiro
• 4th Latin American Forum on Biosimilars
• 2015:
Presented Latin American survey data at two
Biosimilars Conferences in Brazil
• 2016:
FLAB 2016 ( 6th Latin American Forum on Biosimilars)
2016 in Brasília
PANLAR (Pan American League of Associations for
Rheumatology, Panama City)
Patients and Biologics
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About 350 million people around the world are benefiting from a biologic
medicine.
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Biologics are unique medicines used to treat serious, long lasting conditions.
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Many patients take years to find a medicine that works for them to help
control disease:
• Biologic medicines may be the most or even the only effective treatment.
• For patients that are on a biologic that is working for them, decisions related to switching
therapy should be carefully considered.
• Changes in therapy could lead to an immune response and/or a loss of response to the new
and old therapy, exposing patients to a scenario with no or fewer, or more serious treatment
options.
Example: Improved Treatments For CRC Cancer Patients
• Access to new medicines have given our patients TIME and HOPE.
• We’ve gone from one drug to nearly ten in a decade, half biologics.
• The life expectancy of late stage patients has almost TRIPLED, from 11
months to almost THREE YEARS. From “months” to “years”.
• This means more time with their families- meeting their grandchildren,
attending weddings of their children.
The Promise of Biosimilars
• Biosimilars offer benefits to patients:
Increased access to biologic therapies
Lower-cost alternatives
New therapeutic choices
• Available in E.U. and Canada for several years, now in U.S. and Latin
America
• We want to make sure these policies work for patients.
What Are Our Overall Objectives?
• To be unbiased representatives of the patient
community, advocating on critical issues
important to patients.
• Increased access to biosimilars.
• Patient-centered standards for naming,
safety approval and tracking of all biologic
medicines, including biosimilars.
• Informed patient/physician in the case of
substitution of a biosimilar in place of
prescribed biologic.
Learn More
The Alliance for Safe Biologic Medicines:
• www.SafeBiologics.org
• The Global Colon Cancer Association
• www.GlobalCCA.org