Biosimilars Bulletin | September 2021

Thursday October 7, 2021

A Note from Biosimilars Council Executive Director Christine Simmon

September was an exciting month, as we announced the topline findings of our forthcoming 2021 Generic Drug and Biosimilars Savings in the U.S. Report, which once again shows the tremendous savings generated by biosimilars. The report, coming out in October, finds that biosimilar savings more than tripled to nearly $8 billion. Additionally, oncology biosimilars have cut the growth rate for oncology spending roughly in half since 2019. Read our full statement here.

I hope you can join the GRx+Biosims 2021 conference November 8-10, 2021 to discuss the positive news from the savings report and the future of biosimilar medicines in the United States. This year’s event will be held virtually. More information on the biosimilar sessions is here, and please be sure to register. To learn about sponsorship opportunities, please contact us through this form.

— Christine

News & Updates

Record $338 Billion Savings in 2020 from Copy Meds in USA

“Biosimilars are an essential part of the effort to provide affordable and effective medicines to every patient who needs them,” said Christine Simmon, executive director of the Biosimilars Council and senior vice president at the AAM. “Although biosimilars are projected to save the nation $133 billion by 2025, this will only occur if policymakers take steps to encourage greater biosimilar adoption,” she stressed.”

Biosimilars Gain Traction with Regulators and Manufacturers

“The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months. FDA recently approved important new biosimilars for market, updated guidance on follow-on development, and reached agreement with industry on an agenda for advancing biosimilar testing and production over the next five years.”

Biosimilar Medicines Produce Billions in Savings in the U.S., Dramatically Reduce Oncology Spending Growth: Report

“According to the report, the introduction of oncology biosimilar medicines has cut the growth rate of oncology spending roughly in half since 2019. This reduction in growth, along with continued use of generic cancer medicines, contributed to a total of $18 billion saved on oncology medicines in 2020.”

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”

It’s True: Biosimilars Save Money for Medicare

“Biosimilars were touted as an important answer to the problem of soaring drug costs, but whether they’ve had a genuine, measurable impact in the U.S. hasn’t been obvious. Now, two researchers analyzing Medicare Part B spending on biologic drugs have come up with proof, or at least some hard dollar figures approaching it.”

Opinion: FDA Changes to Biosimilar Development Guideline Save Money and Time

“Testing is when something is put through a series of trials to determine its value. Thus, testing is one of the ways to assess something. In this paper, I will draw attention to both substantive and subtle changes to help reduce the cost and time for the approval of biosimilars.”

Biosimilars: Deep Product Understanding Will Move Regulators To Reduce Clinical Data Requirements, US FDA Official Says

“New guidance from UK’s MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.”

Dr. Gary Lyman: Are Interchangeability Designations for Biosimilars Meaningful?

“Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health researcher who has long been an advocate for biosimilars. He has also developed guidelines in support of using biosimilars in the oncology space.”

McKesson’s Catherine Swick Discusses Oncology Biosimilars

“I would say that biosimilars, especially initially, were hard to accept, because people trusted that [original brand] drug they had been using for so many years, but once people got comfortable with the concept of [biosimilar] clinical similarity and what that really meant in terms of effective, safe patient care, we saw that transition happen quickly,” Swick said in an interview with The Center for Biosimilars.”

Featured Resources

Biosimilars create savings

Rituximab Biosimilars Produce Big Cost Savings, Are Effective

“A large Netherlands study demonstrated that rituximab biosimilars (R-biosimilars) produced a 43 percent reduction in annual costs. In addition, three-year overall survival did not differ between diffuse large B-cell lymphoma (DLBCL) and those receiving rituximab, according to the researchers.”


Second Annual IGBA Global Biosimilars Week: Advancing Access — November 1-5

Save the date! Global Biosimilars Week (GBW) is an awareness campaign coordinated by the International Generic and Biosimilar Medicines Association (IGBA). As an IGBA member, AAM and the Biosimilars Council invite you to “join the movement” and share biosimilar content in your own social media channels using daily themes and the hashtag #globalbiosimilarsweek. Learn more.

GRx+Biosims 2021 — November 8-10

Join us for GRx+Biosims 2021 – our virtual conference offers three days of insights and ideas on issues vital to the generic and biosimilar medicines industry. We’ve put together an ambitious program filled with an incredible range of topics, discussions and views from the industry experts you know and trust. Hear from FDA Acting Commissioner Dr. Janet Woodcock and other FDA officials including Drs. Jacqueline Corrigan-Curay, Elizabeth Miller, Sally Choe, Michael Kopcha, Donald Ashley, Gerald Dal Pan, Sarah Yim and more; share knowledge and best practices; and gain insights on navigating regulatory process approvals and the evolving policy landscape.

For information and updates, click here.

Want to hear directly from Executive Director Christine Simmon?

Follow her on Twitter @CSimmon_DC

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.