Biosimilars Bulletin | November 2022

Thursday November 3, 2022

A Note from Biosimilars Council Executive Director Craig Burton

Although we’re entering November, the Biosimilars Council’s efforts to promote biosimilarsare not slowing down.

In mid-October, President Biden signed an Executive Order directing HHS to develop new policy ideas and demonstration programs to reduce prescription drug spending. Increasing biosimilar adoption is a proven way to decrease spending, and the Council will continue to promote options to address perverse incentives and increase biosimilar adoption so that more patients have access to biosimilar medicines.

October marks the recognition of Breast Cancer Awareness Month, and patients battling breast and other types of cancer have particularly benefited from the savings and increased access provided by biosimilar competition. See our latest blog for more information about how biosimilars benefit cancer patients.

This month is also American Pharmacists Month, and the Biosimilars Council continued its efforts to increase education and awareness about biosimilars. We are proud to have collaborated with the American Pharmacist Association on a host of resources to equip pharmacists with accurate information and ensure that pharmacists can help patients benefit from lower-cost biosimilars.

Throughout November, the Biosimilars Council is leading and participating in a number of events including our annual GRx+Biosims conference in North Bethesda, MD and the virtual Global Biosimilars Week. We encourage you to be part of these, so please find further details below and do not hesitate to reach out if we can be helpful.

Craig Burton


GRx+Biosims 2022 

The 2022 GRx+Biosims conference is back in person this fall in North Bethesda, Maryland, and this year, we’re excited to welcome FDA Commissioner Dr. Robert Califf as a keynote speaker.

Our premier scientific and regulatory event for the biosimilars industry brings together some of the brightest minds in the biosimilarsindustry, the government, and the scientific community to share ideas about the future ofbiosimilars and increasing patient access. Register today to gain insights from drug regulators, learn about the latest innovations and emerging technology, and network with others in the industry to gain a fuller understanding of how regulations affect the real world.

If you are not able to join us, you can still follow the conversation on Twitter and LinkedIn at #GRxBiosims.

Global Biosimilars Week: November 14-18

The Biosimilars Council is participating in the International Generic and Biosimilar Medicines Association’s third annual Global Biosimilars Week from November 14-18. This social media campaign raises awareness about the benefits of biosimilar medicines. Over five days, biosimilars advocates and industry representatives from around the world will share key resources, information, and patient stories using the hashtag #GlobalBiosimilarsWeek to help promote more patient access to life-saving, affordable biosimilars.

Click here to learn more about Global Biosimilars Week and how you can join the movement and download the social toolkit for helpful tips and sample messages to promote Global Biosimilars Week on your own channels.

If your organization is already participating in GBW, don’t forget to submit your organization name and logo, and provide a link to resources to appear on the global map.

World Diabetes Day: November 14

The first day of Global Biosimilars Week is also World Diabetes Day. More than half a billion people on the globe suffer from diabetes, and in the U.S., biosimilars are helping many of these patients access more affordable treatment options. Join us on World Diabetes Day to raise awareness and promote better education around diabetes using hashtags #globalbiosimilarsweek #WorldDiabetesDay.

Lung Cancer Awareness Month: November 1-30

In November, we’re standing with the health care industry to raise awareness for lung cancer, the leading cause of cancer deaths in the U.S. Visit the American Lung Association to show your support and share your story. If you use a biosimilar in your treatment or prescribe a biosimilar, share your story on our Biosimilars Patient Resource Center.

FDLI: Essentials of the FDA Landscape for Patient Organizations – November 29–30, 2022 | Virtual Course

AAM is a supporting partner of this virtual, two-day educational program for patient advocates working for 501(c)(3) organizations. The program will bring together legal, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal tools and strategies available for engaging in the medical therapies development process, including interacting with FDA. The knowledge acquired during this course will help patient advocates to successfully accomplish their goals when working with FDA. Learn more and register now.

Access! 2023 – AAM Annual Meeting

Registration is open! 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.

News & Updates

Savings Report Shows the Value of Biosimilars for Patients with Cancer

Each year, more biosimilars continue to reach new patients, delivering greater savings to them, taxpayers, and the American healthcare system. This month, as we come together to raise awareness about the impact of breast cancer, patients and healthcare providers should be encouraged by the record that biosimilars have accrued in reducing the cost of cancer care for patients and their families while increasing their access to the medications they need.

Pharmacists Can Help Spur Greater Biosimilar Adoption

As trusted partners for patients, pharmacists have a critical role to play in educating consumers about biosimilar medicines. Biosimilars are more affordable versions of expensive biologic medicines for patients with a wide range of conditions. Use of biosimilars can reduce costs and expand access to care for patients with conditions such as cancer, arthritis, inflammatory bowel disease, kidney disease, diabetes, macular degeneration, and psoriasis. The pharmacist-patient relationship is unique, with pharmacists providing critical insight and guidance on the proper use of medicines and fostering patient confidence and understanding of biosimilars.

Humira Biosimilars: They’re Coming to America

Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.

FDA To Pilot Biosimilar Regulatory Science Program

As part of BsUFA III, the FDA has announced that it will be commencing its regulatory science research program, which will focus on advancing the development of interchangeable products and biosimilars.

Featured Resources


2022 U.S. Generic & Biosimilar Medicines Savings Report

We are continuing to promote the promising findings of the 2022 U.S. Generic and BiosimilarSavings Report. In 2021, biosimilars generated $7 billion in savings, adding to a grand total of more than $13 billion since 2015. And since the first biosimilar was approved in 2015, biosimilars have been used in 364 million days of patient therapy to date, including more than 150 million days of therapy that would otherwise not have been provided.

We encourage you to share these findings with your networks to help raise awareness for the powerful cost-saving potential of biosimilar medicines. With your help, we can help increase patient access to life-savings, more affordable biosimilars.

Rheumatology Insights: October 2022

Rheumatology Insights is a research-based report designed to explore physician perspectives on key trends impacting the rheumatology field. Rheumatologists face multiple dynamics, from a growing aging population to navigating supply chain shortages of critical therapies. This new report features their perspectives on biosimilars, health equity in rheumatic care and navigating industry trends.

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:



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.