GRx+Biosims 2019 Conference: Advancing Biosimilars Access

Thursday November 21, 2019

Earlier this month the Association for Accessible Medicines (AAM) and its Biosimilars Council hosted the second annual GRx+Biosims Conference for more than 600 attendees from around the world. The jam-packed three-day event featured notable speakers from the U.S. Food and Drug Administration (FDA), industry, payer and patient advocacy groups to discuss how best to increase patient access to safe, effective and competitively priced generics and biosimilars.

GRx+Biosims kicked off with keynotes from FDA leaders Anna Abram, Deputy Commissioner for Policy, Legislation and International Affairs and Dr. Sarah Yim, Acting Director of the Therapeutic Biologics and Biosimilars Office. Both provided updates from the agency on regulatory issues related to the generics and biosimilars industries and underscored their strong support for industry efforts to increase the availability of generic and biosimilar medicines for America’s patients. Each emphasized the FDA’s desire to continue to work closely with industry stakeholders to advance treatment options.

Anna Abram, FDA
Sarah Yim, MD, Office of New Drugs, CDER, FDA

The FDA keynotes were bookended by remarks from former FDA Commissioner Dr. Scott Gottlieb, who continues to be a tireless advocate for generics and biosimilars since his tenure with the FDA concluded. Gottlieb spoke to the importance of creating policies that foster biosimilars, noting that “compared with where we could be, we are much further ahead on biosimilars. We are making headway and should continue to push forward.”

Scott Gottlieb, MD, Former Commissioner, FDA

The program also included a number of interactive panel discussions with high-profile speakers focusing on AAM and council priority issues. The “Breaking Through on Biosimilars” track offered a robust picture of the current state of the industry and encouraged attendees to consider some of the biggest challenges currently facing the biosimilars market, including global harmonization, stakeholder education, payer strategies to drive adoption and the status of the FDA’s 2018 Biosimilars Action Plan.

From left to right: Christine Simmon, AAM, Molly Burich, MS, Boehringer Ingelheim Pharmaceuticals, Inc., James Carey, Merck & Co., Inc., Erika Satterwhite, Mylan, Inc.
From left to right: Andrew Bourgoin, Boehringer Ingleheim Pharmaceuticals, Inc., Sameer Awsare, MD, the Permanente Medical Group, Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, Oncology Nursing Society, and Anna Hyde, MA, Arthritis Foundation
Amy Gutierrez, PharmD, Kaiser Permanente National Pharmacy Programs & Services

Some of the biggest takeaways from this year’s biosimilars track include the ongoing efforts to incorporate the European experience into U.S. biosimilar development and approval, in particular culling from its 12 years of safe and effective biosimilars use and using the plethora of post-marketing surveillance data as a springboard for the U.S. market.

Several sessions explored ways to increase biosimilars market uptake and adoption, including working with insurers to ensure lower-cost biosimilars inclusion on formulary, the importance of continuing to educate medical providers and working with patient groups to ensure  patients have access to accurate information on the safety and efficacy of biosimilars. However, as Chrys Kokino, Head of Global Biologics and Insulin Commercial at Mylan, cautioned on biosimilars policy currently being considered in the U.S., “We need to shift from short-term to a long-term sustainability focus to provide patients treatment options for years to come. The unintended consequences of short-term decisions can impact patients for the future.”

Chrys Kokino, Mylan, Inc.

Stakeholder biosimilar education  also featured prominently throughout several panel discussions. Dr. Sameer Awsare, Associate Executive Director of The Permanente Medical Group; Anna Hyde, Vice President of Advocacy and Access at the  Arthritis Foundation; and Dr. Kelly Willenberg of the Oncology Nursing Society discussed the critical importance of ongoing stakeholder education even as a greater number of biosimilars reach the market, and especially as patients are prescribed biosimilars. As Dr. Awsare noted, “having the physicians, pharmacists and the entire treatment team involved from the beginning and building trust with the patient is critical to biosimilars uptake.”

Sameer Awsare, MD, the Permanente Medial Group

AAM CEO Chester “Chip” Davis Jr. introduced attendees to the AAM “Doesn’t Add Up” campaign, which explores the discrepancy between the increase in FDA approval of lower-cost generics and biosimilars, but a lack of patient access to these crucial alternatives to brand-name medicines. Davis reaffirmed AAM’s and the council’s commitment to ensuring patient access to competitively priced treatments so they don’t have to make a difficult choice between a life necessity and a prescription drug.

Chester "Chip" Davis Jr., CEO, AAM

We hope you enjoyed your time at GRx+Biosims as much as we did. We look forward to seeing you at Access! 2020 in Washington, DC in May.

View GRx+Biosims 2019 Photo Album.

Have an idea for a session at Access! 2020? Contact 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.