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

THANK YOU!

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

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

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: 2014-2016: 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 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 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.

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