Biosimilars Bulletin | August 2022

Thursday September 8, 2022

A Note from Biosimilars Council Executive Director Craig Burton

Last month, we witnessed the final passage and enactment of the Inflation Reduction Act, legislation that could have a profound impact on future biosimilar development. Although the legislation is concerning, I remain confident about the future of biosimilars.

In spite of the challenges they have faced, biosimilars are delivering on their promise – of greater patient access, lower prices and savings for patients and payers alike. We will shortly publish our Annual Savings Report, which will provide an updated assessment of biosimilar savings and the ways in which the biosimilars market is evolving, while highlighting continued opportunities and challenges for policymakers, health care payers and patients.

And as the new drug pricing legislation is implemented, the Biosimilars Council and AAM will be on the forefront of identifying and acting upon opportunities to improve the future of biosimilar availability and adoption to ensure that more patients experience biosimilars’ benefits.

— Craig Burton

News & Updates

Drug Negotiations Will Drive Biosimilars as Patent Tactics Shift

Even without interchangeability, biosimilars on average today cost half as much as the brand name product, Craig Burton, executive director of the Biosimilars Council, said. “They’re bringing savings. But the other thing they’re doing is the brands are reducing their price in order to compete and try to retain market share.”

Health Care Professionals’ Perspectives are Essential to Greater Biosimilar Adoption 

Showcasing trusted medical professionals’ experience is an effective way to combat misinformation and provide a relatable explanation about biosimilars in a way that the underlying data points and study results cannot. We encourage health care professions to visit the Patient Resource Center and share your story to create awareness about the positive impact biosimilars have on patients.

Why Generic Drugmakers Oppose Dems’ Drug Pricing Bill

“We think this potentially sets up a series of perpetual monopolies for the brand products, where sure, they’re going to make less than they would under price controls, but they’re going to make a whole lot more than they would from competition,” said Craig Burton, executive director of the Biosimilars Council.

The High Cost Of The Inflation Reduction Act

The right policy mix to address our current economic malaise is tighter monetary policy and pro-growth tax and regulatory policies. While the Federal Reserve is on the right track for monetary policy, the newly titled Inflation Reduction Act is completely wrongheaded.

Featured Resources

Falling Prices: Biosimilar competition has saved billions of dollars, but policy changes can incentivize billions more 

Biosimilars competition saves patients and the health care system over $11 billion annually and could generate even more savings if the broken drug pricing system were reformed, finds a new issue brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute.

Biosimilars Are Safe for Pregnant Women: Study 

Concerned about potential neonatal immune suppression, the American College of Rheumatology recommends against using biological disease modifying anti-rheumatic drugs (bDMARDs) during pregnancy, but in a retrospective study, Rebecca Scott, BM BCh, MA, PhD, MRCP, and her co-researchers conclude that the evidence goes contrary to this guidance.

IGBA—MOPI Conference 2022 

The conference will provide a great opportunity for participants from the Global, and especially Southeast Asian, off-patent pharmaceutical sector to finally meet again in-person. It will offer a unique chance to address the challenges highlighted by the pandemic as well as the strength and value of this industry. It will also address the local and international policies needed for generic, biosimilar and value-added medicines to become central to global healthcare. Learn More.

AHIP – Unlocking the Promise of Biosimilars in Pharmacy Benefit Management 

During this webinar, Craig Burton will moderate a discussion about how the introduction of self-administered biosimilars can impact the inflammatory disease space by providing patients more-affordable, quality treatment options. Speakers will also provide a regulatory background on biosimilar and interchangeable products, discuss how biosimilars promote competition and health system savings and talk about the benefits they can bring to patients and health insurance providers by lowering costs. Learn More.

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.

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


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.