Biosimilars Bulletin | December 2022

Tuesday January 10, 2023

A Note from Biosimilars Council Executive Director Craig Burton

As we close out 2022 and move into 2023, we are excited about ongoing progress in moving biosimilars forward. Most recently, this includes the Biosimilars Council’s new webpage that showcases research on the safety and effectiveness, as well as savings, of biosimilars. We hope this will be a valuable resource for patients, health care providers, and even policymakers who wish to better understand biosimilars.

In addition, IQVIA published another must-read report illustrating the positive impact that shared savings programs can have on increasing biosimilar adoption and savings.

Overall, we witnessed continued advancements in the biosimilars market in 2022 as you’ll see from some of the most popular resources and articles below. And the new year promises to be just as active as this market continues to evolve. AAM and the Biosimilars Council will be kicking off the year at our annual conference Access! 2023, February 13-15, and the International Generic and Biosimilar Medicines Association’s 25th Annual Conference, February 15-16, and hope you will be able to join us in Orlando, Florida.

We are grateful for your engagement and support and are looking forward to working with you to continue to promote biosimilar adoption in 2023. If you are not already following us on Twitter, Facebook, YouTube, or LinkedIn, we encourage you to do so to stay up to date on the latest biosimilar news, data and stakeholder perspectives.

Happy New Year,

Craig Burton

Major News & Resources From 2022

GRx+Biosims 2022 Conference Recap

AAM and the Biosimilars Council hosted guests in North Bethesda, Maryland for the 2022 GRx+Biosims Conference. This conference proved an unparalleled opportunity for biosimilars professionals to engage with regulators and industry experts, gain new insights on biosimilars regulatory issues, learn about the latest innovations and technical advances, and network with other industry leaders.

IQVIA: Semglee Experience Can Help Predict Adalimumab Biosimilar Adoption

IQVIA outlined what stakeholders can glean from the U.S. experience with Semglee and identified implications for U.S. market introduction of biosimilars referencing Humira (adalimumab).

Savings Report Shows the Value of Biosimilars for Patients with Cancer

Each year, more biosimilars reach new patients, delivering greater savings to them, taxpayers, and the American health care system. As we raise awareness about the impact of breast cancer, patients and health care providers should be encouraged by the record of biosimilars in reducing the cost of cancer care for patients and their families while increasing their access to the medications they need.

Medicare Gives Biosimilars Boost, First Step in Drug Pricing Law

Medicare will now pay more for lower-cost version of certain physician-administered drugs, the first step for the Biden administration implementing a new sweeping drug-pricing law.

The public health insurance program primarily for seniors will increase what it pays for biosimilars that costless than their brand -name competitor in Medicare Part B for the next five years, starting Oct. 1.

New Report: Generics, Biosimilars Saved $373 Billion

The U.S. healthcare system saved $373 billion in 2021 by using generic and biosimilar drugs, according to a new report. In addition, the total generic and biosimilar savings in Medicare for 2021 was $119 billion, while the total savings for commercial plans was $178 billion, according to the Association for Accessible Medicines (AAM)’s 2022 U.S. Generic & Biosimilar Medicines Savings Report.

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.”

Guest Blog: The Biosimilars Council Launches a New Educational Resource for Patients – July 11, 2022

Today, many patients are confronted with high costs to access their medicines, which sometimes forces them to choose between their physical and financial health. Thankfully, biosimilar medicines may help patients avoid these tough decisions. The Biosimilars Council launched the Biosimilars Patient Resource Center to answer patient questions about these important, lower-cost treatment options. Of course, patients should always consult with their doctor about their medications.

Industry Hails Access Implications As FTC Promises PBM Probe

The US FTC’s announcement of an inquiry into PBMs will be music to the ears of the country’s generics and biosimilars industry, which has long called for action on abusive practices that undermine access.

Association for Accessible Medicines Names Craig Burton as Senior Vice President, Policy & Strategic Alliances, and Executive Director of the Biosimilars Council

The Association for Accessible Medicines (AAM) and its Board of Directors announced the promotion of Craig Burton to Senior Vice President, Policy & Strategic Alliances, effective May 30, 2022. He will also become the Executive Director of the Biosimilars Council, which is the preeminent voice advocating in Washington and the states for policies to improve access to more affordable alternatives to expensive biologic medicines.

HHS OIG Report Demonstrates Need for Changes to Part D to Increase Biosimilar Use

Biosimilars provide more options for care at a lower cost for patients, but due to Medicare’s perverse incentives, many PBMs and health plans have been slow to prioritize biosimilars, leavings savings on the table. The HHS Inspector General (OIG) released an analysis that drives home just how poorly Medicare plans perform when it comes to making FDA-approved biosimilars available to America’s seniors.

Access! 2022 Conference Recap

Biosimilars Council Executive Director Christine Simmon led a roundtable discussion on “Leveraging Biosimilar Competition for Success.” The panelists highlighted the success of the biosimilars industry in recent years.


Access! 2023 – AAM Annual Meeting – February 13-15, 2023 (Orlando, Florida)

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 and register today.

25th IGBA Annual Conference hosted by the Association for Accessible Medicines (AAM) – February 15-16, 2023 (Orlando, Florida)

Come join your colleagues from around the world to network and discuss challenges and opportunities for the global generics and biosimilars industries. For the first time since 2014, IGBA’s Annual Conference is being held in the United States, in conjunction with AAM’s Access! 2023 Annual Meeting. Learn more and register today.

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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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.