Increase Patient Access to Biosimilars in 2022

Friday February 4, 2022

Last year was full of exciting developments for patients who rely on biosimilars. Here’s a look at what we’re working on at the Biosimilars Council in 2022.

This will be a unique year because Congress will formalize and advance legislation that includes the reauthorization of the biosimilars user fee agreement, known as BsUFA. Last year, the Biosimilars Council was one of the lead negotiators with the Food and Drug Administration (FDA) throughout a lengthy process that culminated in a performance goals agreement. This serves as the foundation for the BsUFA reauthorization and includes pilot programs for the FDA to explore ways to advance the development of interchangeable biologics and improve the efficiency of biosimilar product development. We look forward to working with Congress to pass and the agency to implement this important legislation.

In addition to BsUFA, we will also focus throughout the year on ensuring a competitive marketplace for biosimilars. According IQVIA data, savings from biosimilars increased more than 800% from 2018 to 2020. These savings are projected to reach over $30 billion annually by 2022, with over $130 billion in savings by 2025.

Efforts like the drug price negotiation framework of the recent Build Back Better Act put these savings in jeopardy. It is likely that many of the biosimilars currently in development would no longer be commercially viable because of the significant uncertainty that such a market transformation would create. The end result would leave patients and payers in the commercial market dependent on high-cost brand drugs, increasing costs for patients, taxpayers and the overall health care system, and depriving them of the significant savings and access that biosimilars provide.

We know that biosimilar competition works for patients, and the Biosimilars Council is committed to working with policymakers to build on biosimilars’ successes and remove barriers that limit options for care and leave savings on the table. For example, there is an opportunity for the Administration to implement a demonstration program that would evaluate the benefits of providing a shared savings payment for biosimilars utilization in Medicare Part B.

More biosimilars are becoming available in the pharmacy, and this new venue will provide challenges and opportunities for biosimilar adoption. We will continue our work to ready stakeholders for the launch of adalimumab biosimilars in 2023 by ensuring that pharmacists and patients have the information they need to make informed decisions. In the pharmacy space, the Administration has taken steps toward allowing biosimilars placement on formularies as they become available to health plans. We continue to explore ways to make these actions more effective, and look forward to working with the Administration to do so. Please check our action center for ways to demonstrate your support and make your voice heard.

To complement our advocacy efforts, the Biosimilars Council and AAM will host events throughout the year to connect biosimilar manufacturers with patients and other stakeholders:

We are excited see everyone in person February 14-16 at Access! 2022. This is an invaluable opportunity for peers and industry leaders to hear first-hand from world-renowned speakers and discuss what the future holds for our industry. Biosimilars are an integral part of this conference, and during the “Leveraging Biosimilar Competition for Success,” session, panelists will assess how various stakeholders leverage biosimilar competition today, and the threats and opportunities on the horizon.

In November, we are looking forward to hosting top technical, regulatory and policy professionals at GRx+Biosimilars 2022. This event is the premier scientific and regulatory event for the U.S. generics and biosimilars industry, where subject matter experts share their knowledge and best practices to enhance attendees’ understanding of regulatory process and approvals and how to succeed in generic and biosimilar development.

Finally, we will be updating the Biosimilars Council’s website throughout the year to make it easier for patients and policymakers to find accurate information about biosimilars. As part of this process, we are also enhancing our brand, giving our digital presence a new look that is in line with our role as the preeminent association for biosimilars manufacturers and stakeholders. We are excited to unveil a new logo soon, so watch this space!

As 2022 gets underway, we welcome your feedback and engagement on these priorities and activities in furtherance of our shared mission to improve U.S. patient access to biosimilars.

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 20 percent of total drug spending.

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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.