1. Latin American Biologics/Biosimilars Conference
Presented by the Alliance for Safe Bioloigic
Medicines & the Global Colon Cancer Association
Andrew Spiegel, Esquire

2. THANK YOU!

3. Introduction Andrew Spiegel, Esq. Patient Advocate since 1998
Co-Founded the Colon Cancer Alliance
Executive Director of the Global Colon Cancer Association (GCCA)
Chair, Digestive Disease National Coalition
Board Member, International Association of Patient Organizations (IAPO)
Co-Founder and Steering Committee Member of the Alliance for Safe Biologic Medicines

4. 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 composed of patient and physician groups
International Advisory Board of physicians, researchers, pharmacists, and patients
66 members on 5 continents and growing
STEERING COMMITTEE

5. 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.

6. Sharing Physician Perspectives With Regulators
Europe:
: 58th-63rd WHO INN Consultation and Frontpage meetings
2014: Presented European data European commission, and country-specific survey data to Spain, Italian, Health Ministries
2015: World Biosimilars Congress- Basel, Switzerland
2016: Biosimilars Labeling Conference, Brussels, Belgium
North America:
2014: Present Canadian Survey data to Health Canada
2015: Shared U.S. data and recommendations with U.S. Dept. of Health and Human Services and other Administration officials.
2016: Three FDA Arthritis Advisory Committee Hearings
Numerous U.S. State Legislatures

7. 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) in Brasília PANLAR (Pan American League of Associations for Rheumatology, Panama City)

8. Patients and Biologics
About 350 million people around the world are benefiting from a biologic medicine.
Biologics are unique medicines used to treat serious, long lasting conditions.
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.

9. 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.

10. 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.

11. 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.

12. Learn More The Alliance for Safe Biologic Medicines:
The Global Colon Cancer Association