Biosimilars Bulletin | May 2022

Wednesday June 8, 2022

A Note from Former Executive Director Christine Simmon 

As many of you have already heard, May was my last month leading the Biosimilars Council, and I could not be prouder of the work we accomplished during my tenure since co-founding the Council in 2015 and leading it as Executive Director since. From the early days of explaining that “yes – the science is there,” for biosimilar approvals, to today’s advocacy priorities around reimbursement and adoption, our collective leadership in this sector has moved the needle. Together we have educated key stakeholders about biosimilars, and worked with FDA, CMS, FTC and state and federal policymakers to promote their approval and utilization. Your expertise, engagement, participation, and wise counsel are the keys to the Biosimilar Council’s successes. Our important work continues, but we have already made a difference for millions of America’s patients – a tremendous achievement!

So, thank for your partnership. I have enjoyed working with you and your teams over the years, and I have learned so much. I am very pleased that Craig Burton will be succeeding me as the Executive Director of the Council. Craig has an unparalleled understanding of the policy landscape and true passion for helping patients, and I am excited to see the progress that will be made under his leadership.

Together with Steve Selde and all of our AAM colleagues who work on biosimilars priorities, we will continue our representation of your interests so that biosimilars, and the patients who use them, can thrive.

– Christine Simmon

A Note from Biosimilars Council Executive Director Craig Burton

In my new role as Executive Director, I look forward to continuing to work with members of the Biosimilars Council and other stakeholders to ensure that these life-saving therapies reach a greater number of patients.

Since its formation, the Biosimilars Council has been the leader in shaping a legislative and regulatory environment that fosters biosimilar competition and increases patient access to care, in large part due to the efforts and direction of my good friend Christine who has made a lasting impact on our mission. l am enthusiastic about the opportunity to work with our members, as well as patients, providers and other stakeholders, to build upon this strong foundation, starting with the exciting launch of our new Biosimilars Patient Resource Center, about which you can read more below. Working together, we can ensure that biosimilars fulfill their promise of expanding health care for patients in the years to come.

– Craig Burton

News & Updates

Everything You Need to Know About Biosimilars – All in One Place 

Biosimilar medicines are revolutionary therapeutics that treat patients at a fraction of the cost of brand-name biologics. However, public awareness and trust of biosimilars is still evolving, meaning many patients and providers are overpaying for expensive brand-name biologics. To address this education gap, the Biosimilars Council launched a new, one-of-a-kind educational resource: the Biosimilars Patient Resource Center. Our Digital Toolkit includes assets that can be used to create your own content as your organization works to share accurate and up to date information about biosimilars.

Sandoz Launches New Global Health Inequalities Initiative 

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. The initiative is supported by a multidisciplinary Steering Committee of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders from around the world, with a mission to increase global adoption of biosimilar medicines by at least 30% in 30+ countries by 2030.

Australia’s Biosimilar Awareness Week 

The week aims to broaden the conversation on biosimilar medicines and to recognise the role of biosimilar medicines in supporting a world class health system. As a virtual event, GBMA Education has developed a range of posts across our social channels – both for the consumer audience on Facebook, along with HCP and industry messages for LinkedIn and Twitter.

Biosimilars Can Help Lower Patient Drug Costs When the Right Teams Come Together: Prime Therapeutics Executive 

Innovation isn’t always guaranteed to succeed. High-potential ideas sometimes don’t take off like we thought they would. And in recent years, many of us in the pharmacy and medical space have wondered if biosimilars would be in that category. But early evidence shows these medications hold great promise when it comes to lowering costs and providing effective therapies.

AAM Calls for Federal Trade Commission to Investigate PBM Business Practices 

On May 23, 2022, the Association for Accessible Medicines and its Biosimilars Council urged the Federal Trade Commission (FTC) to investigate the competitive impact of pharmacy benefit managers (PBMs) and their various abusive behaviors that undermine patient access to safe, affordable pharmaceutical care. In a letter responding to the FTC’s request for information “on the ways that large, vertically integrated PBMs are affecting drug affordability and access,” AAM outlines key PBM business practices that have a negative impact on America’s patients and the long-term sustainability of the nation’s competitive generics and biosimilars drug markets.

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.

New House Bill Could Expand User Fee Programs for Biosimilars 

A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics. HR 7667, also known as the Biosimilar User Fee Amendments of 2022, was introduced by Representative Anna Eshoo (D-California) and Health Subcommittee Ranking Member Brett Guthrie (R-Kentucky). It has been referred to the House Committee on Energy and Commerce. According to Bloomberg Law, the committee voted 30-0 to advance the measure.

Featured Resources

How a Biosimilar Reaches a Patient

How a Biosimilar Reaches a Patient

This infographic lays out the process for how biosimilars are developed, approved, and prescribed, so that you can make more informed decisions.

Increase Patient Access to Lower-Cost Biosimilar Medicines

View this infographic to learn more about three legislative proposals that will reduce barriers and help biosimilars reach their full potential for patients.

Biosimilars Made a Significant Dent on 2021 Drug Spending 

By imposing restraints on prescription drug spending, biosimilars were a major bright spot in 2021, according to a new report by Eric M. Tichy, Pharm.D., MBA, BCPS, of Mayo Clinic, and his fellow researchers, who drew their data from the IQVIA National Sales Perspectives database. Overall, pharmaceutical expenditures in 2021 were up 7.7% to $576.9 billion compared with 2020, Tichy and his coauthors wrote in the American Journal of Health-System Pharmacy. But for community hospitals, overall spending went down significantly for three top drugs with biosimilar competition.


GRx+Biosims 2022 – November 7-9, 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. Register now.

Global Biosimilars Week 2022 – November 14-18

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.

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn @jcraigburton

Interested in joining the Biosimilars Council?

Contact Jewel Smith ( for more information.

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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.