Biosimilars Bulletin | April 2020

Monday May 4, 2020

Each month, the Biosimilars Council sends a newsletter with the latest updates in the biosimilars industry including policy movement, educational resources and upcoming events. To stay current on biosimilars, sign-up to receive these monthly updates on the form to the right.

News and Updates

Our COVID-19 response is focused on ensuring patients have access to their biosimilar medicines. During this challenging time, we have consolidated recommendations from government experts and responses to frequently asked questions about biosimilar medicines and housed them on a page at the page below. We will continue to keep these materials updated and share any new information on the Biosimilars Council social media channels.


Now more than ever, we appreciate your support and continued engagement. You can help others by sharing these resources in your social networks while our members continue to work on meeting the health care needs of America’s patients.

COVID-19 and AAM: FAQs

The coronavirus (COVID-19) pandemic is disrupting everyday life around the world and imposing unprecedented stress on our health care system. Here are responses to frequently asked questions, from the perspective of the U.S. generics and biosimilars industry.

Christine Simmon Discusses the Purple Book, Patents and Biosimilars

Biosimilars Council Executive Director Christine Simmon discussed the Purple Book and how it will affect biosimilar makers and illuminate patent hurdles at the recent FDA/Federal Trade Commission workshop on anti-competitive practices.

Biosimilars in an Election Year: What To Expect

As election season approaches and drug prices remain a central part of the candidates’ platforms, Biosimilars Development editor Anna Rose Welch spoke with Executive Director Christine Simmon about several leading policy efforts that are front of mind for the Council.

Biosimilars could disappear if the Supreme Court overturns the ACA

If the Supreme Court takes the unthinkable step of overturning most – or all – of the ACA, the regulatory pathway for biosimilars would essentially disappear overnight. That would have ramifications for millions of patients who would no longer see more affordable biosimilar versions of high-cost biologic treatments reach the market. (Opinion Article by Carol Lynch, President of Sandoz U.S. and Head of North America)

Study: Employers Can Save With Biosimilars

On March 31 The ERISA Industry Committee released research findings of the potential savings to employers and employees from using more biosimilars. The study, which coincides with the 10th anniversary of the law that created biosimilars, found that although biologics make up less than 1% of prescriptions, they account for 40% of employers’ total drug spending.

Featured Resources

patient access to biosimilars

Increase Patient Access to Lower-Cost Biosimilar Medicines

The three legislative proposals outlined in this one-pager would help strengthen biosimilar adoption and each is designed to ensure savings for patients and Medicare.

Physician Biosimilar Testimonials

Check out the newest Biosimilar Council resource, in which physicians discuss the benefits and promise of biosimilars.

Upcoming Events

GRx+Biosims 2020

Planning + Ready Join us November 9-11, 2020 in North Bethesda, Maryland for GRx+Biosims 2020. GRx+Biosims is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory and policy professionals. Hear from top-in-their-field officials and subject-matter experts; share knowledge and best practices; and gain insights on navigating the regulatory process approvals and the evolving policy landscape.


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

Stay Informed

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Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



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.