The GRx+Biosims 2024 conference, recently held in Rockville, Maryland, brought together stakeholders from across the pharmaceutical, healthcare, and regulatory landscapes to discuss the transformative potential of generic and biosimilar medicines. With a shared commitment to improving patient access to high-quality, affordable treatments, the conference provided an essential platform for engaging in dynamic discussions about policy, innovation, and the future of generics and biosimilars.
The conference kicked off with opening remarks from AAM’s Executive Vice President, David Gaugh, and the association’s new President and CEO, John Murphy III. John highlighted the significant role of generics and biosimilars, noting, “Generic and Biosimilar Medicines represent 90% of prescriptions dispensed, but only 13% of total drug spending,” setting the stage for discussions on improving access to affordable medications.
Another big thank you to AAM Executive Vice President, David Gaugh, and President & CEO, John Murphy III for getting #GRxBiosims underway this morning. During his opening remarks, Johnn shared that, “#Generic & #Biosimilar Medicines represent 90% of prescriptions dispensed, but… pic.twitter.com/eQoX7eWnrl
— AAM (@AccessibleMeds) October 21, 2024
Following the opening, David Gaugh presented Dr. Janet Woodcock with a Lifetime Achievement Award, recognizing her 38 years of service at the FDA. In a fireside chat, Dr. Woodcock reflected on her career and shared insights on biosimilar interchangeability, emphasizing the potential for trusted scientific evidence to accelerate market acceptance without the need for costly clinical studies.
A sincere thank you to Dr. Janet Woodcock, who shared her thoughts on interchangeability this morning with #GRxBiosims attendees:
“With #biosimilars, when it comes to reframing the way we look at interchangeability, I see this opening the door to not doing extensive, expensive… pic.twitter.com/fdOOyir9yZ— AAM (@AccessibleMeds) October 21, 2024
The session was followed by a keynote address from Dr. Iilun Murphy, Director of the Office of Generic Drugs (OGD), CDER FDA, who provided valuable perspectives on the future of generics and biosimilars from a regulatory standpoint.
We appreciate Iilun Murphy, M.D., Director, Office of Generic Drugs (OGD), CDER FDA , who delivered an impactful keynote address to help open the first half of day one, for #GRxBiosims 2024! Thank you for your time and expertise! pic.twitter.com/IShjxKGIva
— AAM (@AccessibleMeds) October 21, 2024
Following the CDER Keynote Address, attendees dove into the Learning Tracks sessions, which covered critical topics such as Biosimilar Interchangeability, Improving the Quality of ANDA Submissions, and Addressing Solutions for Drug Shortages.
Diving deep into essential topics, including Interchangeability, Issues to Improve ANDA Submission Quality and Solving Drug Shortages at #GRxBiosims @BiosimsCouncil pic.twitter.com/KlsSXfT12Y
— AAM (@AccessibleMeds) October 21, 2024
After a productive networking lunch, Day One concluded with insightful discussions on key topics, including drug supply challenges, nitrosamines and harmonization, legal insights on the Biosecure Act, device requirements for biosimilars, ANDA approval timelines, electronic submissions, and USP excipient nomenclature.
Jumping back in, following a wonderful networking lunch, on important topics including: New Challenges to the Drug Supply (from an agency perspective), Nitrosamines and Harmonization and A Legal Overview of the Biosecure Act. We are grateful for the timely insights for all SME… pic.twitter.com/FLQ3vHE71j
— AAM (@AccessibleMeds) October 21, 2024
Closing out our learning opportunities today, at GRxBiosims, with insights on Device Requirements for Biosimilars & Interchangeable Biosimilars, Securing Timely Approvals of ANDAs, Electronic Submissions, and USP Excipient Nomenclature. Another round of applause for our… pic.twitter.com/aY1ey78FaD
— AAM (@AccessibleMeds) October 21, 2024
Day Two of GRx+Biosims 2024 kicked off with key insights from notable speakers from the FDA:
- Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars, FDA
- Michael Rodgers, Associate Commissioner for Inspections and Investigations, Office of Inspections and Investigations (OII), FDA
- Elizabeth Miller, Pharm D, Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA), FDA
A giant thank you to Dr. Yim, for her partnership, expertise and thoughtful comments today, to kick-off Day Two of #GRxBiosims! pic.twitter.com/mSFdfX9I0s
— AAM (@AccessibleMeds) October 22, 2024
A huge thank you to Michael Rodgers, for his participation and leadership this morning! #GRxBiosims pic.twitter.com/Fgkw07rqQV
— AAM (@AccessibleMeds) October 22, 2024
Great info in our main #GRxBiosims room this morning—thank you Elizabeth Miller! pic.twitter.com/qFvCiGd6hI
— AAM (@AccessibleMeds) October 22, 2024
The morning continued with a series of informative panels, covering topics such as Multi-Attribute Method and Non-Clinical Immunogenicity Studies, Biosimilar Interchangeability, Generic Drug Price Combinations and Product and Quality Threats and Opportunities.
A huge thank you to our panelists— for their time and expertise on Multi-attribute Method & Non-clinical Immunogenicity Studies, #Biosimilar Interchangeability, #Generic Drug Price Combinations and Product & Quality Threats and Opportunities! #GRxBiosims pic.twitter.com/QrnfQ8l859
— AAM (@AccessibleMeds) October 22, 2024
In the afternoon, Learning Tracks continued, focusing on Biosimilars, Science & Regulatory Affairs, and Legal & Policy Issues. Participants engaged in discussions tailored to the key areas of the generic and biosimilar industries most relevant to their work.
Our final round of learning track sessions has begun! Thank you to all SMEs and panelists, as well as attendees for your participation! #GRxBiosims pic.twitter.com/LyWXuuqHlX
— AAM (@AccessibleMeds) October 22, 2024
Day Two wrapped up with a lively exposition, encouraging collaboration across industry sectors. A key highlight was the participation of FDA OGD and OPQ project managers, underscoring the importance of open communication between regulators and industry. Attendees gained valuable insights into the regulatory landscape and key policy initiatives shaping generics and biosimilars.
And now: The #GRxBiosims Expo! Attendees in Rockville, MD will now begin an interactive knowledge sharing session, bringing together multiple levels of scientific disciplines from diverse spaces across the #generic and #biosimilar industries. And stay tuned on X for updates! pic.twitter.com/LJwhl66KNS
— AAM (@AccessibleMeds) October 22, 2024
The final day of GRx+Biosims 2024 began with an exclusive fireside chat featuring FDA Commissioner Robert Califf, M.D., MACC, moderated by AAM Executive Vice President, David Gaugh. This was followed by the State of the Generic Medicine Industry keynote address from AAM Board Chair Keren Haruvi.
A great conversation covering an array of topics from supply chain, to drug shortages and the exciting possibilities for biosimilars. Thank you for your partnership @DrCaliff_FDA @US_FDA pic.twitter.com/XUW8yWD5Zz
— AAM (@AccessibleMeds) October 23, 2024
Thank you for your leadership, Keren! @Sandoz_Global pic.twitter.com/uzA3W6hFsg
— AAM (@AccessibleMeds) October 23, 2024
Next, Craig Burton, AAM’s Senior Vice President of Policy and Strategic Alliances, led a “Biosimilars Market Leaders Discussion” with experts from Sandoz Inc., Teva Pharmaceuticals USA, and Biocon Biologics. The session highlighted the crucial role of regulatory agencies in advancing biosimilar development and improving patient access to essential treatments.
A huge thank you to our panelists, for their thoughtful expertise! #GRxBiosims @Sandoz_Global @TevaUSA @BioconBiologics pic.twitter.com/Jz5wX8YcTQ
— AAM (@AccessibleMeds) October 23, 2024
“Interchangeability is a regulatory designation. With the FDA taking necessary steps to alleviate this, means we need legislation to step up as well.” —Sonia Oskouei, PharmD, VP & U.S. Head, Biosimilars and Specialty, Sandoz
Next, AAM’s Giuseppe Randazzo moderated an “Ask A Regulator” panel with experts from CDER, FDA.
A big thank you to our SME panelists from @US_FDA pic.twitter.com/Ez1LROSBR0
— AAM (@AccessibleMeds) October 23, 2024
“Our main priority is to streamline biosimilar development.” —Emanuela Lacana, PhD, Deputy Director, OTTB, OND, CDER, FDA.
The final keynote speaker was Jacqueline Corrigan-Curay, JD, M.D., Principal Deputy Center Director at CDER, FDA.
Thank you, Dr. Corrigan-Cury, for sharing your expertise! #GRxBiosims pic.twitter.com/vY9eN3yFoX
— AAM (@AccessibleMeds) October 23, 2024
GRx+Biosims 2024 was a great success, thanks in large part to the support of our sponsors and exhibitors. Their partnership helped make this event possible, and we deeply appreciate their commitment to advancing the generics and biosimilars industry. We look forward to continuing to work together to improve patient access to affordable medicines.
- Platinum sponsor: Teva Pharmaceuticals USA, Inc.
- Gold sponsor: Apotex Corp.
- Gold sponsor: DifGen Pharmaceuticals
- Business Lounge sponsor: USP
- Mobile App sponsor: Zydus Pharmaceuticals USA, Inc.
- Wifi sponsor: Sandoz Inc.
- Bronze sponsor: Lupin Inc.
- Breakout Session sponsor: Biocon Biologics Limited
- Patron sponsor: Dr. Reddy’s Laboratories
- Patron sponsor: Raaha LLC
That’s a wrap for Day One of #GRxBiosims 2024! A big thanks to our sponsors, who helped make today’s event possible. Join us tomorrow for Day Two of the #generic and #biosimilar industry regulatory, science and policy event of the year! pic.twitter.com/Hgi34hyNwl
— AAM (@AccessibleMeds) October 21, 2024
A final thank you to all speakers, attendees, sponsors, AAM staff and members—#GRxBiosims 2024 was a success because of you! pic.twitter.com/CpueHp9uuX
— AAM (@AccessibleMeds) October 23, 2024
To see more photos from this year’s conference, click the button below.
By Jennifer Soup, Director, Meetings & Marketing
Published on November 8, 2024