Overview
Tutorial: October 18*
Meeting: October 19-20
*Tutorials require registration and are an additional fee
With the approval of the first biosimilars in the US and potentially more to follow, and with expiration of patents for originator biologicals, the market for biosimilars is poised to grow at a rapid pace. These biosimilars and follow-on biologics have garnered great interest presenting new market opportunities for industry and potential for cost-effective benefits in patient care.
As biosimilars become more available to patients, there are important factors for patients and health care providers that must be addressed. This meeting will focus on the innovations, technologies, and regulatory information surrounding biosimilars. This is an exciting time in our industry. DIA’s Biosimilars 2015 is the ideal time to hear from FDA and international agencies – What will they expect in biosimilars going forward?
This two-day interactive meeting will include topics on:
- US and Global Regulatory Developments
- US and Global Commercial Considerations
- Biosimilars in the US
- Quality Considerations
- Clinical Considerations
- Biosimilars in Oncology
- Interchangeability
- The Payer Perspective
- And More
Program Committee
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Cecil J. Nick, MS FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom -
Stan Bukofzer, MD Corporate Vice President and Chief Medical Officer
Hospira, Inc., United States -
David Gaugh, RPh Senior Vice President for Sciences and Regulatory Affairs
Generic Pharmaceutical Association (GPhA), United States -
Sundar Ramanan, PhD Director, Global Biosimilars R&D Policy
Amgen Inc., United States -
Julie Ann Rosenberg, MD Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health
Pfizer, Inc., United States -
Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada -
Joerg Windisch, PhD Chief Science Officer
Sandoz Biopharmaceuticals, Austria -
Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States
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