On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. The two-day event was set up to establish a global network of individual patient experts and discuss pressing issues related to the access of drugs and health technology.
The afternoon session was devoted to the issue of biosimilars or Subsequent Entry Biologics (SEB) as they are referred to in Canada. Dr. Dolinar gave an introductory presentation on biologics and biosimilars and how they differ from chemical drugs and why these differences matter to patients. He also discussed how Canada and Europe have each established a science-based patient-centered approach to approving biosimilars that should serve as a model for the U.S. Food and Drug Administration (FDA).
Michael Reilly followed Dr. Dolinar’s presentation with an overview of biosimilars in the U.S. and an update on the FDA approval process. He then discussed the importance of personalizing health policy and provided a case study on how patient advocates can help change policy for the better. Finally, Reilly stressed the need for patients to have information and tools available to help guide policy decisions.
Following the presentations, Dr. Dolinar and Reilly participated in a panel discussion with Ken Hughes, vice president of scientific & regulatory affairs for R & D and Karen Burke, director of regulatory affairs for Amgen. The four panelists summarized the afternoon session on biosimilars/SEBs and then fielded questions from the patient experts in the audience.
Durhane Wong-Rieger ended the session by emphasizing the need to continue the momentum created by the meeting and offered to provide minutes and create a facebook page for all participants to stay connected.