Streamlined Biosimilar Development: Global Challenges and Opportunities
Monday, November 8, 2021
1:00 p.m. - 2:00 p.m.
Governments, insurers and patients looking for lower-cost alternatives to costly biologic drugs are increasingly turning to biosimilars. But biosimilars, despite their promise to lower costs without compromising safety or efficacy, are still a small fraction of prescription therapies used today. Part of the reason is the high cost of development and regulatory requirements that vary among countries. If governments can harmonize development programs and regulatory requirements, it could spur biosimilars investment and growth and encourage a more efficient development system that is based on product quality. This session will include discussion of what a harmonized global development and regulatory paradigm should look like.
Moderator: Aaron Josephson
Director, Regulatory Policy & Intelligence, Teva Pharmaceuticals
Hillel Cohen, PhD
Executive Director, Scientific Affairs, Sandoz Inc.
Director General, Health Canada
Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER, FDA
Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals