Biosimilars Council Recap of Access! 2019

Friday February 22, 2019

Earlier this month in New Orleans, the Association for Accessible Medicines and its Biosimilars Council hosted our annual Access! Conference. Attendees from member companies, regulators, media and government took over the Big Easy to talk about how to increase patient access to safe, effective and competitively priced generics and biosimilars.

Attendees enjoying the Welcome Reception at Access! 2019

AAM was thrilled to welcome Health and Human Services Secretary Alex Azar who voiced full-throated support for generics and biosimilars. The Secretary lauded the leadership of the Administration, including Food and Drug Administration Commissioner Scott Gottlieb, M.D., and Centers for Medicare and Medicaid Services Administrator Seema Verma, in prioritizing generics and biosimilars competition in the dialogue around decreasing patient health care costs and congratulated the industry on the strides made to date. He encouraged manufacturers to rise to the challenge of continuing to increase access for patients through the development of competitive alternatives to expensive brand-name medicines. (Missed the livestream? Watch it here).

The program also included a number of highly decorated speakers and engaging panel discussions. Former NBC News Chief Medical Editor Nancy Snyderman, M.D., emceed the event, offering insight and commentary to advance the discussion around increasing patient access to generics and biosimilars. While the Access! sessions focused on a variety of industry topics, biosimilars were at the center of discussion throughout the event, specifically the current industry outlook and how brand “shenanigans” are threatening to derail biosimilars uptake.

Carol Lynch, Sandoz U.S. President and Head of North America, detailed biosimilars successes globally as well as the challenges currently facing the industry, specifically citing misinformation campaigns as a major hurdle that “…at best this leads to confusion, [and] at worst… leads to a lot of doubt about biosimilars and their efficacy.” Lynch then turned to an esteemed panel featuring I-MAK Co-Founder and Co-Executive Director Tahir Amin and Sanford C. Bernstein & Co. Senior Analyst Ronny Gal to offer potential solutions.

Carol Lynch, President of Sandoz US and Head of North America, Speaking During the “Biosimilars Shenanigans – Can They Be Stopped?” Session

The panel, moderated by Kurt R. Karst, Director of Hyman, Phelps & McNamara, P.C., highlighted several major obstacles facing the nascent U.S. biosimilars market including anti-competitive tactics employed by originator manufacturers to thwart biosimilar competition such as access to samples for biosimilar developers, the use of “rebate traps” and exclusionary contracting to exclude biosimilars from payer coverage, and the deployment of “patents thickets” to keep approved biosimilars off of the market.

The panelists highlighted the CREATES Act as a key solution to the access to samples issues as well as recent Administration action regarding the treatment of rebates and formulary tiering in federal programs as a potential solution to watch in that space. To tackle patent thickets Tahir Amin indicated that a reassessment of current pharmaceutical patent laws may be warranted.

Access! Attendees were also treated to a dynamic Health Care Leaders Luncheon discussion featuring some of the industry’s most influential female executives, including Rebekah Gee, M.D., Secretary, Louisiana Department of Health; Carol Lynch, President, Sandoz U.S.; Silvia Perez, President and General Manager, 3M Drug Delivery Systems; and Frances Zipp, President and CEO Lachman Consultant Services Inc.

Healthcare Leadership Luncheon with some of health care’s most influential female executives including: Nancy Snyderman, M.D., FACS, Physician and Former NBC News Chief Medical Editor; Rebekah Gee, M.D., Secretary, Louisiana Department of Health; Carol Lynch, President of Sandoz U.S. and Head of North America; Sylvia Perez, President & General Manager, 3M Drug Delivery Systems; Frances Zipp, President & CEO, Lachman Consultant Services, Inc

The Biosimilars Council thanks all our speakers and attendees for making Access! 2019 an amazing and engaging event. We look forward to continuing to work to ensure the development of a robust biosimilars market in the United States Events like Access! 2019 spark the expert dialogue to help address some of the industry’s most pressing issues. We look forward to seeing everyone next year!

Register for GRx+Biosims 2019

If you enjoyed Access! 2019 or were able to attend GRx+Biosims 2018, you may be interested in joining us from November 4 -6 for the second annual GRx+Biosims conference. More information is available on the AAM website and we hope that you choose to join us.

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 23 percent of total drug spending. Additional 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.