Advancing Generic and Biosimilar Development, Review, Approval, and Market Entry
Monday, November 2, 2026
1:15 p.m. - 2:15 p.m.
This session will explore recent and emerging Administration and FDA initiatives intended to support generic and biosimilar development, review, approval, and market entry. Discussion may include programs such as the ANDA Prioritization Pilot, with a focus on how these initiatives may affect regulatory strategy, development timelines, approval predictability, and patient access to affordable medicines.
Moderator: Kimberly Maxfield, PhD, MPH
Director of U.S. Regulatory Affairs, Biocon Biologics
Kalpana Vanam
Senior Vice President, Regulatory Affairs, U.S., Lupin Pharmaceuticals
Janet Vaughn
Senior Vice President, Regulatory Affairs – North America, Sandoz Inc.
Cory Wohlbach
Global Vice President Biosimilar Regulatory Affairs, Teva Pharmaceutical
