Biosimilars Bulletin | September 2022

Thursday October 6, 2022

A Note from Biosimilars Council Executive Director Craig Burton

September marks the culmination of a significant amount of the Biosimilars Council’s work, with a number of new progress to share. First and foremost, AAM and the Biosimilars Council are pleased to share the publication of our annual 2022 US Generic & Biosimilar Medicines Savings Report. The report shows that increasing use of biosimilars generated more than $7 billion in savings in 2021, an increase of more than 50 percent in one year. Since the first biosimilar approval in 2015, biosimilars have generated more than $13 billion in savings and have been used in more than 364 million days of patient therapy. Most importantly, IQVIA estimated that biosimilars resulted in more than 150 million days of patient therapy that would otherwise not have been provided, increasing patients’ access to care.

But there is more that we can do to ensure that biosimilars reach patients. The pharmacy community is a critical partner in that effort, so we are pleased to have collaborated once again with the American Pharmacists Association (APhA) to update their “Biosimilar Basics for Patients” and “Show You Know Biosimilars” resources. These resources are designed to introduce pharmacists and patients to biosimilars and answer questions they may have related to their safety and efficacy. These partnerships are critical to educating a broader audience of stakeholders who will benefit most from access to these lower-cost alternatives.

Finally, CMS took important steps to implement the temporary increase in the biosimilar add-on payment to ASP+8 percent. This has been one of the biosimilar community’s key priorities, and it marks a positive change by which CMS will encourage greater adoption of biosimilars.

But there is more to be done. Over the next few months, the Biosimilars Council will continue its work to communicate the value of biosimilars. In addition, the Council continues to work with member companies and stakeholders on issues affecting biosimilars as the Administration implements the recently-enacted Inflation Reduction Act. If you are not already following us on TwitterFacebookYouTube, or LinkedIn, we encourage you to do so to so you can stay up to date on the latest biosimilar news, data, and stakeholder perspectives.

— Craig Burton

News & Updates

2022 U.S. Generic and Biosimilar Savings Report: Biosimilars Deliver on Their Promise

The 2022 U.S. Generic and Biosimilar Savings Report, the annual report from the Association for Accessible Medicines and its Biosimilars Council, showed once again that biosimilar medicines are critical to lowering drug prices for patients and the health care system. Featuring data from IQVIA, the Savings Report found significant year-over-year growth in savings and increased treatment options for patients, highlighting how biosimilars are delivering on their promise.

‘Incorrect’ To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA 

U.S. FDA India country director Dr. Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.

Rebate Walls May Thwart Biosimilar Savings

Humira’s biosimilars will save the healthcare system an estimated $5 billion or so a year, cutting costs for providers and patients. Biosimilars will likely be about half the price of Humira, which is $84,000 for a year of treatment. But, AbbVie may manipulate the rebates associated with Humira to limit competition and the potential savings from lower-cost biosimilars.

Featured Resources

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Biosimilar Basics for Patients

This brochure describes biologic medications and a type of biologic known as biosimilars, which are highly similar to biologics but are typically less expensive for patients. The information is designed to help you make informed decisions about your health care treatment options.

Show You Know Biosimilars

Biosimilar products are beginning to enter the U.S. health care system. These products offer the potential to reduce costs, improve access to care, and increase treatment options for patients. Pharmacists have important roles in providing care for patients, including those who are taking biosimilar products. Test your knowledge of biosimilars with this short quiz.


Biosimilars: Are they the same quality?

Biosimilars offer incredible promise to provide increased access to potentially lower cost treatments for patients with chronic conditions, from diabetes to cancer. USP and the FDA created an educational resource to help patients and health care providers talk about biosimilars product quality.


GRx+Biosims 2022 

GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries featuring timely programming relevant to technical, regulatory, policy professionals. Top officials and subject matter experts share their knowledge and best practices to enhance attendees’ understanding of how to succeed in generic and biosimilar development, regulatory process and approvals, and the evolving policy landscape. Learn more.

Global Biosimilars Week 2022 

The International Generics and Biosimilars Medicines Association (IGBA) is hosting its third annual Global Biosimilars Week. This event raises awareness of the powerful impact of biosimilar medicines and provide key resources for advocates and interested parties. This year’s theme is, “Strengthening Healthcare – the Value of Biosimilar Medicines.” Learn More and download the social toolkit.

Access! 2023 – AAM Annual Meeting

Save the Date! Meet the leaders and decision-makers who are shaping the future of generics and biosimilars. Be inspired by new experiences, real talk and fresh ideas during a period of intense challenges and exciting promise. Join generic and biosimilar industry professionals at Access! 2023. Learn more.

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn

Interested in joining the Biosimilars Council?

Contact Jewel Smith ( for more information.

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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:



Registration Opens Soon. October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the premier 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.