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
Nimi Chhina, PhD, JD
Vice President, Global Regulatory Affairs Operations, Policy & Intelligence, Teva Pharmaceuticals
Rajeev Mathur, PhD
Senior Vice President, Global head of Regulatory and Business Continuity, Sun Pharmaceuticals
Kalpana Vanam, MBA
Senior Vice President (Gx, Biosimilars and Specialty), Lupin Pharmaceuticals
Janet Vaughn
Senior Vice President, Regulatory Affairs – North America, Sandoz Inc.
