GRx+Biosims 2021 Conference Recap

Monday November 29, 2021

AAM’s 2021 GRx+Biosims conference has officially come to a close, and by all accounts it delivered on its promise to provide attendees informative and timely discussions on the direction of the biosimilars industry. The many expert panelists brought insightful viewpoints about the biosimilars landscape and the opportunities to continue expanding this critical industry.

The virtual conference began with an opening address from AAM CEO Dan Leonard, who expressed his optimism for the biosimilars industry, with promising data from the 2021 U.S. Generic and Biosimilar Medicines Savings Report. As we heard throughout the conference, biosimilars were responsible for $7.9 billion in savings in 2020, a three-fold increase from 2019, and total savings are forecast to reach more than $130 billion by 2025. However, as Dan emphasized, Congress must support policies to help patients fully realize the potential savings from these life-saving medicines, stating:

“As Congress is spending so much time and energy wrangling over how to deal with the ever-increasing price of brand-name medications, I encourage legislators to realize that biosimilars and generics alike are the solution to high drug costs and the only proven prescription for savings. Instead of merely working to reign in brand-name prices, they should work to proactively incentivize biosimilars from development to launch and leverage the proven power of market competition from our products to generate savings for taxpayers, job creators and, most importantly, patients.”

Dan Grx

Following Dan’s opening address, the conference featured keynote speakers who focused on biosimilars. FDA Acting Commissioner Dr. Janet Woodcock gave an overview of the industry’s growth in 2021. Dr. Woodcock lauded the addition of the first interchangeable biosimilar products as part of the roster of the 31 approved biosimilar products. “We’ve had a very positive and productive year in the FDA’s biosimilars program,” she explained.

Dr. Sarah Yim, Director of the FDA’s Office of Therapeutic Biologics and Biosimilars, emphasized that by leveraging Biosimilar User Fee Amendment (BsUFA) programs, the FDA is “going to do some additional things to help advance the development of interchangeable biosimilars.”

Kristi Martin, Senior Advisor, Centers for Medicare & Medicaid Services, concluded the opening day keynote addresses by discussing ways in which biosimilars are promoting market competition to lower drug prices:

“Echoing the president’s Executive Order, we know that promoting competition is one way to make drugs more affordable. When the markets function well, competition from generic and biosimilar medicines provide tremendous value in cost savings to both patients and our government programs.”

For the remainder of the virtual conference, discussion of the biosimilars industry took place over a series of panel discussions with key industry leaders and experts. Biosimilars Council Executive Director Christine Simmon led a roundtable discussion on “Ensuring Biosimilar Sustainability” featuring Keren Haruvi, President of Sandoz US and Head of North America, Sandoz Inc.; Anshuman Patwardhan, Senior Vice President, Global Licensing & Business Development – Biologics, Lupin Pharmaceuticals; and Paul Thomas, Chief Commercial Officer – United States, Biocon Biologics Inc. In their discussion, the panelists examined the vital role that manufacturers play in the development of biosimilars.

Christine panel

Additionally, a panel of industry experts discussed best practices for biosimilar adoption during the session, “Increasing Biosimilars Adoption: Providers’ and Patients’ Perspectives.” Melissa Andel, Principal, CommonHealth Solutions, moderated the session, with Anna Hyde, Vice President, Advocacy & Access, Arthritis Foundation; Kathy Oubre, Chief Operating Officer, Pontchartrain Cancer Center; and Eric Tichy, Vice Chair, Pharmacy Supply Solutions, Mayo Clinic, each providing experiences in promoting the use of biosimilars. Panelists stated that more can be done to improve biosimilar adoption, such as an increase to physician reimbursement, which the BIOSIM Act, now before Congress, provides.


During the session, “Medicare Part D and Opportunities to Increase Biosimilars and Generics Utilization,” Craig Burton, VP Policy, AAM, moderated a discussion with John Brooks, Partner, South Capitol; Sarah D’Orsie, Vice President, Government Affairs and Policy, Fresenius Kabi; and Massey Whorley, Associate Principal, Avalere Health, about policy opportunities to increase generics and biosimilars use. This panel discussed the changes to Medicare Part D being contemplated by Congress and the data supporting additional opportunities to increase seniors’ access to biosimilars under the program.


AAM and the Biosimilars Council are grateful to everyone who participated in this year’s event, from those who led our keynote speeches to those who joined to learn about biosimilars for the first time.

Attendees can use the same login information to sign into the GRx+Biosims 2021 virtual platform. All recordings are available for replay until the end of February 2022. For those who missed the conference, please reach out to Jennifer Soup for session availability.

We hope you will continue to stay up to date on the latest biosimilars news and resources by following the Biosimilars Council on social media and subscribing to our newsletter. Access! 2202, AAM’s annual meeting, will be held in person February 14-16 in Orlando, Florida. For more information, click here.

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 18 percent of total drug spending.  

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 at

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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.