AGENDA
- All
- MONDAY, NOVEMBER 2, 2026
- TUESDAY, NOVEMBER 3, 2026
- WEDNESDAY, NOVEMBER 4, 2026
MONDAY, NOVEMBER 2, 2026
8:00 a.m. – 4:30 p.m.
Registration
MONDAY, NOVEMBER 2, 2026
8:00 a.m. – 9:00 a.m.
Networking Breakfast
MONDAY, NOVEMBER 2, 2026
8:45 a.m. – 8:55 a.m.
Welcome and Introduction
John Murphy III
President & CEO, AAM
MONDAY, NOVEMBER 2, 2026
8:55 a.m. – 9:10 a.m.
GDUFA IV and BsUFA POCs/SMEs Recognition
Giuseppe Randazzo, M.S.
Senior Vice President, Sciences and Regulatory Affairs, AAM
Senior Vice President, Sciences and Regulatory Affairs, AAM
MONDAY, NOVEMBER 2, 2026
9:10 a.m. – 9:40 a.m.
Keynote Speaker Address
MONDAY, NOVEMBER 2, 2026
9:40 a.m. – 10:10 a.m.
OGD Keynote Address
Director, Office of Generic Drugs, CDER FDA
MONDAY, NOVEMBER 2, 2026
10:10a.m. – 10:45 a.m.
Networking Break
MONDAY, NOVEMBER 2, 2026
10:45 a.m. – Noon
GRx+Biosims Learning Tracks
MONDAY, NOVEMBER 2, 2026
12:00 p.m. – 1:15 p.m.
Networking Luncheon
MONDAY, NOVEMBER 2, 2026
1:15 p.m. – 2:30 p.m.
GRx+Biosims Learning Tracks
MONDAY, NOVEMBER 2, 2026
2:30 p.m. – 2:45 p.m.
Networking Break
MONDAY, NOVEMBER 2, 2026
2:45 p.m. – 4:00 p.m.
GRx+Biosims Learning Tracks
MONDAY, NOVEMBER 2, 2026
4:00 p.m. – 5:00 p.m.
Networking Reception
TUESDAY, NOVEMBER 3, 2026
8:00 a.m. – 9:00 a.m.
Science and Regulatory Working Group (members only)
TUESDAY, NOVEMBER 3, 2026
8:00 a.m. – 9:00 a.m.
Networking Breakfast
TUESDAY, NOVEMBER 3, 2026
9:00 a.m. – 9:30 a.m.
Biosimilars Keynote Address Fireside Chat
Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER, FDA
Moderator: Giuseppe Randazzo, M.S.
Senior Vice President, Sciences and Regulatory Affairs, AAM
TUESDAY, NOVEMBER 3, 2026
9:30 a.m. – 10:00 a.m.
OII Keynote Address
Elizabeth Miller, PharmD (Invited)
Acting Deputy Associate Commissioner for Inspections and Investigations (DACII), FDA
TUESDAY, NOVEMBER 3, 2026
10:00 a.m. – 10:45 a.m.
Medicines Supply Chain Resiliency Panel
TUESDAY, NOVEMBER 3, 2026
10:45 a.m. – 11:00 a.m.
Networking Break
TUESDAY, NOVEMBER 3, 2026
11:00 a.m. – 12:15 p.m.
GRx+Biosims Learning Tracks
TUESDAY, NOVEMBER 3, 2026
12:15 p.m. – 1:30 p.m.
Networking Lunch
TUESDAY, NOVEMBER 3, 2026
1:30 p.m. – 2:45 p.m.
GRx+Biosims Learning Tracks
TUESDAY, NOVEMBER 3, 2026
2:45 p.m. – 3:00 p.m.
Networking Break
TUESDAY, NOVEMBER 3, 2026
3:00 p.m. – 5:00 p.m.
GRx+Biosims Exposition
TUESDAY, NOVEMBER 3, 2026
5:00 p.m. – 6:00 p.m.
Networking Reception
TUESDAY, NOVEMBER 3, 2026
6:00 p.m. – 8:00 p.m.
Dinner & Entertainment
Step into an evening where science meets celebration at the GRx+Biosims 2026 Dinner and Entertainment event. Enjoy a dynamic atmosphere inspired by innovation, collaboration, and discovery while USP’s house band, The Impurities, delivers a high-energy performance featuring rock-and-roll, punk, country, and pop favorites spanning decades—plus original material of their own. Known for energizing USP events, local venues, and major industry gatherings, The Impurities will keep the momentum going with a setlist designed to bring colleagues and industry peers together for a memorable night of music, connection, and fun.
Sponsored By:
WEDNESDAY, NOVEMBER 4, 2026
7:45 a.m. – 8:45 a.m.
Networking Breakfast
WEDNESDAY, NOVEMBER 4, 2026
8:00 a.m. – 8:45 a.m.
Biosimilars Council Meeting (members only)
WEDNESDAY, NOVEMBER 4, 2026
8:30 a.m. – 8:45 a.m.
State of the Industry Keynote
Bob Hoffman
AAM Board Chair
WEDNESDAY, NOVEMBER 4, 2026
8:45 a.m. – 9:45 a.m.
Panel Discussion
WEDNESDAY, NOVEMBER 4, 2026
9:45 a.m. – 10:00 a.m.
Networking Break
WEDNESDAY, NOVEMBER 4, 2026
10:00 a.m. – 11:00 a.m.
Global and U.S. Generics and Biosimilars: Trends, Issues and Outlook
Scott Biggs
Director, Supplier Services, IQVIA
WEDNESDAY, NOVEMBER 4, 2026
11:00 a.m. – 11:45 a.m.
Biosimilars Market Leaders Discussion
WEDNESDAY, NOVEMBER 4, 2026
11:45 a.m. – 12:45 p.m.
CEO’s Unplugged
WEDNESDAY, NOVEMBER 4, 2026
12:45 p.m.
Closing Remarks
John Murphy III
President & CEO, AAM
WEDNESDAY, NOVEMBER 4, 2026
12:45 p.m. – 2:00 p.m.
Farewell Luncheon – Grab + Go
*Agenda is subject to change
