GRx+Biosims 2022 Conference Recap

Earlier this month, AAM and the Biosimilars Council hosted guests in North Bethesda, Maryland for the 2022 GRx+Biosims Conference. This conference proved to be an unparalleled opportunity for biosimilars professionals to engage with regulators and industry experts, gain new insights on biosimilars regulatory issues, learn about the latest innovations and technical advances, and network with other industry leaders.

Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research at the FDA, kicked off the conference with a fireside chat on the FDA’s work to encourage generic and biosimilar development and competition. Dr. Cavazzoni emphasized the FDA’s commitment to working with biosimilar industry partners, noting that “the generics and biosimilars industries are essential to patient access.”

Conference attendees heard from numerous policy and industry professionals as well as regulators who shared their insights on the future of biosimilars development and competition. Sarah Yim, M.D., Director of the FDA’s Office of Therapeutic Biologics and Biosimilars, provided a keynote address with updates about BsUFA III implementation and the FDA’s educational efforts. Dr. Yim highlighted the importance of 2023, noting that the “biosimilar marketplace is at an inflection point with good progress being made… It’s still early for patient self-administered products. But 2023 will be a big opportunity for the market.”

.@US_FDA Dr. Sarah Yim at #GRxBiosims: "#Biosimilar marketplace is at an inflection point with good progress being made...It’s still early for patient self administered products. But 2023 will be a big opportunity for the market." @BiosimsCouncil #biosimilars #FDA pic.twitter.com/DCGdNDpLy6

— AAM (@AccessibleMeds) November 7, 2022

The conference also had a dedicated Biosimilars Learning Track where attendees heard from breakout panels covering a range of topics, from BsUFA III implementation to global regulatory harmonization, the current state of the biosimilars market and the Inflation Reduction Act’s implications for biosimilar development.

Biosimilars Council members also had the opportunity to meet with Dr. Yim to discuss the regulatory landscape in more detail. Additionally, Dr. Meena Seshamani, Deputy Administrator and Director of the Center for Medicare, and Kristi Martin, Senior Advisor in the Center for Medicare, discussed agency efforts to work with industry on the implementation of the Inflation Reduction Act. Through this meeting and the broader conference, the Biosimilars Council built upon its unique role as the leader for the biosimilars community in the U.S.

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

Finally, the discussions wrapped up with the Biosimilars Leadership Roundtable, in which industry leaders reviewed the state of biosimilars and future challenges and opportunities. Ali Ahmed, Senior Vice President of Biosimilars at Fresenius Kabi USA; Chrys Kokino, President of U.S. BioPharma at accord BioPharma; and Harsher Singh, Senior Vice President at Amneal Biosciences highlighted the challenges facing biosimilars but struck a positive note as they emphasized the value of biosimilars in expanding patient access to care.

The Biosimilars Council is grateful for everyone who took part in these critical discussions about the path forward for biosimilar competition. We look forward to continuing the conversation next year in Orlando, Florida at Access! 2023. Running from February 13-15, Access! 2023 will be followed by the 25^th annual conference of the International Generic and Biosimilar Medicines Association from February 15-16. You can register for both conferences today, and we hope you will be able to join us. Until then, stay up to date on the latest biosimilars news and resources by following the Biosimilars Council on social media and subscribing to our newsletter.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 20 percent of total drug spending.