Fireside Chat between FDA Commissioner Dr. Robert Califf and AAM’s Interim President and CEO, David Gaugh at GRx+Biosims 2023 in North Bethesda, MD

GRx+Biosims 2023 Conference Recap

GRx+Biosims 2023, the highly anticipated conference for the generics and biosimilars industry, recently concluded in North Bethesda, Maryland. The event served as a platform for in-depth discussions led by prominent experts and key figures from both the government and industry sectors. Over the course of three days, critical conversations unfolded, paving the way for significant developments that will enhance patient access to cost-effective medications.

The conference commenced with an engaging Fireside Chat between FDA Commissioner Dr. Robert Califf and AAM’s Interim President and CEO, David Gaugh. Participants gained valuable insights into the FDA's ongoing efforts to ensure the availability of safe, effective, and affordable generics and biosimilars.

The conference continued with key insights shared by three notable speakers from FDA:

  • Dr. Iilun Murphy, Director, Office of Generic Drugs
  • Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality
  • Francis Godwin, Director, Office of Manufacturing Quality

“Year 1 was a successful transition into GDUFA III. FDA and industry have a shared goal of ensuring generic drugs are available.” —Dr. Iliun Murphy

Day 1 concluded on a high note with an informative session featuring the USP forum, exploring ways in which the United States Pharmacopeia can support manufacturers in overcoming challenges. The session offered attendees a valuable opportunity to learn, engage, and contribute to the future of generics and biosimilars.

Day 2 of the GRx+Biosims 2023 conference featured insightful remarks from AAM Board Chair Christine Baeder of Teva Pharmaceuticals. Her keynote address highlighted the significant challenges and promising opportunities that the generic and biosimilar industry is currently facing. As a leader in the field, her perspective shed light on the crucial developments and key initiatives shaping the industry's trajectory.

“But our industry is facing dire threats to the very fabric of its existence. From economic challenges to unrealistic, unpredictable, policy frameworks squeezing our manufacturers. We are at a crossroads for how we can best serve and support the patients who need us the most.The future of the savings provided by generic drugs in the last 20 years will depend on the health of the biosimilars industry. Overcoming these obstacles means quite literally life or death for the millions upon millions of patients we serve around the country.” —Christine Baeder

Up next was Dr. Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA). She shed light on the critical role of regulatory oversight in ensuring the safety and efficacy of medical products, emphasizing the agency's commitment to upholding robust standards.

“The nearly 3 years of the public health emergency fundamentally changed the world, how we work, and how we approach important challenges and opportunities.” —Dr. Elizabeth Miller

Day 2 of the GRx+Biosims 2023 conference concluded with an engaging exposition, fostering an environment of collaborative knowledge sharing and interaction among various industry sectors. One of the key highlights was the participation of more than 50 project managers from FDA's OGD and OPQ, underscoring the significance of transparent communication and information exchange between regulatory authorities and industry experts. This unique opportunity for direct engagement with FDA representatives provided attendees with valuable insights into the regulatory framework and policy initiatives driving the generics and biosimilars industry.

The final day of the GRx+Biosims 2023 conference commenced with a fireside chat featuring Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars (OTBB) within the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), FDA. This conversation explored the pivotal role of regulatory agencies in advancing the development and approval of biosimilars, contributing to greater patient access to vital treatments.

The fireside chat was led by Craig Burton, AAM's Senior Vice President of Policy and Strategic Alliances and Executive Director of the Biosimilars Council. This dynamic exchange emphasized the collaborative approach taken by both regulatory authorities and industry stakeholders in navigating the evolving landscape of biosimilars.

Dr. Sarah Yim on Interchangeability “becomes a source of confusion for people… To try and combat confusion, we wanted to take the focus away from the two designations. We’re really trying to tamp down all the misinformation about interchangeability that’s out there.”

The GRx+Biosims 2023 conference came to a close with an insightful session featuring Dr. Jacqueline Corrigan-Curay, Principal Deputy Director of the Center for Drug Evaluation and Research (CDER) at the FDA. Her valuable perspectives shed light on the future of the pharmaceutical industry, emphasizing the critical role of collaboration and innovation in ensuring the accessibility and quality of generic drugs and biosimilars for patients worldwide.

Dr. Corrigan-Curay's remarks underscored the significance of regulatory frameworks that support the development and approval of generic drugs and biosimilars, contributing to improved healthcare outcomes and affordability.

“Medicines only work if patients have access. The generic and biosimilar industries have made outstanding contributions to public health by increasing access and affordability.” —Dr. Jacqueline Corrigan-Curay


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Jennifer Soup—Director, Meetings & Marketing

By Jennifer Soup, Director, Meetings & Marketing
Published on October 18, 2023

Association for Accessible Medicines


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