Back Together: GRx+Biosims 2022 Conference Recap

For the first time in three years, GRx+Biosims - the premier scientific and regulatory event for the generics and biosimilars industry - convened in North Bethesda, Maryland. Bringing together top experts and leaders in government and industry, the three-day event featured important conversations that will shape the future of our industry and help secure greater patient access to lower cost medicines.

AAM CEO Dan Leonard kicked off the event with a speech outlining the incredible success of generic and biosimilar medicines at reducing drug costs. Our industry has now become the backbone of the American health care system, he noted, giving a look at what’s new, what’s now, and what’s next for generics and biosimilars.

Following Dan’s opening remarks, Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, provided key insights into the regulatory state of play for generics and biosimilars, touching on key items like the latest user fee amendments and the importance of industry-government cooperation. We really believe that the generics and biosimilars industries are essential to patient access, she said.

Attendees then had the opportunity to hear from other key leaders at CDER diving deep into their work to support an efficient regulatory structure for medical approvals, hearing from Principal Center Deputy Director Dr. Jacqueline Corrigan-Curay, Director of the Office of Therapuetic Biologics and Biosimilars Dr. Sarah Yim, and a panel of leaders representing the scope of the Center’s work that was hosted by AAM Senior Vice President for Sciences and Regulatory Affairs David Gaugh. In her remarks, Dr. Corrigan-Curay stressed the importance of raising patient awareness about the importance of generic and biosimilar medicines.

“Patients are their own best advocates. Getting the message out to patients is important.”


Kicking off day two, three more leaders from CDER gave further insights into the departments work to expand patient access to generics and biosimilars – Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD); Dr. Michael Kopcha, Office of Pharmaceutical Quality (OPQ); and Donald Ashley, JD, Director, Office of Compliance (OC). These experts made clear the FDA’s commitment to securing a strong pharmaceutical pipeline, ensuring the quality of medicines for patients, and helping the industry navigate legal compliance.

Later that day, Elizabeth Miller, PharmD, from the FDA’s Office of Regulatory Affairs (ORA) gave an in-depth presentation about the agency’s work to maintain a steady pace of manufacturer inspections during the pandemic and beyond. In her remarks, she specifically thanked partners like AAM and the Biosimilars Council for fighting on behalf of patients in important regulatory negotiations.

To start day three, Dan Leonard took the stage once more to have a fireside chat with the CEO of U.S. Pharmacopeia, Ronald Piervincenzi. In their discussion, Dr. Piervincenzi stressed the importance of innovation and stakeholder cooperation at expanding patient access to safe, effective, and more affordable generics and biosimilars.

Finally, Biosimilars Council Executive Director Craig Burton hosted a panel of three biosimilars industry leaders: Ali Ahmed, Senior Vice President, Biosimilars, Fresenius Kabi USA; Chrys Kokino, President, U.S. BioPharma, Accord BioPharma; and Harsher Singh Senior Vice President, Amneal Biosciences. In their discussion, these leaders praised the rapid expansion of the biosimilars market, and outlined what challenges the industry faces as it works to increase uptake and drive down costs for patients.

Outside of informative speeches and breakout sessions, attendees at GRx+Biosims had an unparalleled ability to interact with one another. Events like the GRx+Biosims Exposition, Women in Health Policy mixer, and even a bowling night helped attendees build new relationships, share important ideas, and have a few laughs.

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

View Conference Photos


This year’s GRx+Biosims conference was truly one for the books, and we were so happy to get together in person for this exciting event. This February, we will get together once again for Access! 2023, AAM’s annual meeting which will be held in Orlando, Florida. Click here to learn more and sign up today.


Erica Klinger—Senior Director, Marketing

By Erica Klinger, Senior Director, Marketing
Published on November 23, 2022

Association for Accessible Medicines


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