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.

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.

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.

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.

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.


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

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.

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.

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.

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.

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.

“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.

“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.

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.

To see more photos from this year’s conference, click the button below.

View Facebook Photo Album

 

By Jennifer Soup, Director, Meetings & Marketing
Published on November 8, 2024