Biosimilars Council 2019 Year in Review

Thursday January 30, 2020

2019 was a whirlwind year for biosimilars, highlighted by a record 10 U.S. Food and Drug Administration (FDA) approvals and increased uptake and utilization rates by payers. As former FDA Commissioner Scott Gottlieb observed, despite the significant challenges the U.S. biosimilars market faces,  the “value proposition and the opportunities when it comes to biosimilars” is unparalleled, and stakeholders must continue to work in concert to fulfill their promise to increase access and savings for America’s patients.

U.S. Department of Health and Human Services Secretary (HHS) Alex Azar echoed this sentiment during AAM’s Access! 2019 conference saying, “Biologic drugs, today, represent almost 40 percent of prescription drug spending. The challenges are real, but so is the potential for [biosimilar] competition and savings.”

2019 – A Watershed Year for Biosimilars Education

The European Union has more than 700 million patient days of safe and efficacious biosimilar use. To elevate the European biosimilars experience, the Biosimilars Council partnered with the International Generics and Biosimilars Association to launch an educational video campaign that addresses the underlying science behind originator biologic and biosimilar development and approval in easy-to-understand terms for prescribers and patients.

In June, Kaiser Permanente Medical Group Internal Medicine Physician and Associate Executive Director Sameer Awsare, M.D., sat down with the Biosimilars Council to talk about biosimilars, their benefits and the hurdles to adoption in the U.S. He also answered common stakeholder questions related to this innovative class of medicine from his unique provider perspective:

2019 also saw the Biosimilars Council launch its Member Spotlight series, first featuring Hillel Cohen, M.D., Executive Director, Scientific Affairs, Sandoz, Inc. Dr. Cohen shared his thoughts on  increasing patient access to biosimilars through stakeholder engagement and education.

Dr. Cohen discussed how misguided FDA policy related to the naming of biosimilars and a lack of clarity from the agency on what it means when a biosimilar is “interchangeable” has led to stakeholder confusion and slowed uptake and utilization by providers and patients alike.

You can watch the full conversation with Dr. Cohen here.

Interested in learning more about interchangeability? Watch our video, Interchangeability 101.

interchangeability vs biosimilar

Want to know more about biosimilar suffixes and naming? See our infographic the breaks down the concept into easily understandable terms.

importance of naming biosimilars

United States-Mexico-Canada Agreement

The United States-Mexico-Canada Agreement (USMCA) dominated headlines throughout 2019. Hidden within the initial trade deal were provisions that would have given brand-name manufacturers expanded market monopolies at the expense of patient access.

However, working with a broad stakeholder coalition, AAM and the Biosimilars Council were able to eliminate these provisions from the deal. In early December, the Congressional Trade Working Group and the Administration reached a deal on a revised agreement that represents victory for patients. The revised text creates greater opportunities for patients in Mexico, Canada and the United States to access less expensive medicines and promotes a competitive pharmaceutical market across the three countries.

failure to launch white paper

Biosimilars Failure to Launch

Despite the significant advances in stakeholder understanding of biosimilars, brand-name manufacturers continue to use anti-competitive tactics to protect their monopolies to the detriment of America’s patients. To highlight these abuses, the Biosimilars Council released a series of white papers highlighting that delayed biosimilar launch and market uptake as a result of anti-competitive tactics by brand-name biologic manufacturers, in addition to market access barriers, have cost America’s taxpayers and patients nearly $10 billion since 2015.

These analyses are and continue to be a component of a larger campaign by AAM and the Council. The #DoesntAddUp campaign aims to raise awareness among stakeholders of the significant challenges to the generics and biosimilars industry and how greater availability of these medicines can increase savings and access for patients and the healthcare system.

Want to learn more? Read the full white papers here and here, and visit

The Council looks forward to a promising 2020 and continuing our work to increase patient access to competitive biosimilars. We continue to develop and share new resources for patients, physicians, payors and policymakers regularly, which are available on our website, blog, Biosimilars Handbook and Toolkit.

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.