Biosimilars Bulletin | August 2021

Tuesday September 7, 2021

Each month, the Biosimilars Council sends a newsletter with the latest updates in the biosimilars industry, including policy movement, educational resources and upcoming events. To stay current on biosimilars, sign up to receive these monthly updates on the form to the right.

A Note from Biosimilars Council Executive Director Christine Simmon

This month, the Biden administration again referred to biosimilars by name in a White House fact sheet on increasing access and lowering the price of prescription medicines. While much remains to be seen about the specifics of Congress and the Administration’s work on this issue, we are encouraged by the Administration’s stated goal of “accelerating the development and uptake of generic and biosimilar drugs that give patients the same exact clinical benefit but at a fraction of the price.” Over the next weeks and months, we will continue to pursue and create opportunities to elevate biosimilars and the value they provide across our health care system.

On that note, I am pleased to announce that AAM and the Biosimilars Council will be hosting our annual GRx+Biosims 2021 conference November 8-10. I invite you to join us to discuss the future of biosimilar medicines in the United States. This year’s event will be held virtually. Information and registration are available here. To learn about sponsorship opportunities, please contact us through this form.

— Christine

News & Updates

Approval of First Interchangeable Biosimilar Insulin to Increase Competition With Payer Contracts: GlobalData

“When it comes to insulin choice, price is currently the biggest barrier, as insulin brand preference is primarily determined not by a doctor, but through payer contracts with pharma companies, according to GlobalData. The company, in a statement, said that while patients will be increasingly prescribed Viatris/Biocon’s Semglee (biosimilar insulin glargine-yfgn) over Sanofi’s Lantus (insulin glargine) due to its competitive pricing, Semglee’s commercial success will be limited due to the declining use of the first-generation long-acting insulins.”

Dr. Neal Dave Explains Why Biosimilars Should Be Favored Over Reference Products

“Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, discusses the potential for biosimilar utilization to grow and the reasons why his practice favors them over reference products.”

Advocacy Groups Call for Zero Co-Pay Policy on Biosimilars

“A group of 16 patient advocacy organizations has asked CMS and HHS to consider establishing a zero co-pay policy for Medicare Part B patients, a move the groups said would improve access to biosimilars and save seniors in Medicare as much as $3 billion in out-of-pocket costs.”

FACT SHEET: President Biden Calls on Congress to Lower Prescription Drug Prices

“Alongside other steps, the federal government will be working with states and Tribes to import safe, lower-cost prescription drugs from Canada and accelerating the development and uptake of generic and biosimilar drugs that give patients the same exact clinical benefit but at a fraction of the price.”

Biosimilars Move to Center Stage

“Despite years of disappointment, recent progress has fueled predictions for significant growth in biosimilars, even before FDA’s action on Semglee. A report from IQVIA issued in October 2020 predicted an accelerated increase in biosimilar approvals and sales that will yield $100 billion in savings over five years. As biotech therapies account for a larger portion of the prescription drug market, the analysts expect an increase in biosimilar development programs and greater uptake of these competitive products by prescribers and patients.”

2020 Spend and Trend Report Shows Biosimilar Competition Led to Decreases in Originator Prices, Claims

“In the report, the authors examined market trends for several biosimilars on the US market, many of which are indicated for use in the oncology and rheumatology spaces, from 2018 to March 2021. The report covers how biosimilars have impacted the prices and claims for reference drugs. The authors also estimated the potential savings that plan sponsors could generate depending on how much of their patient populations are switched to biosimilar versions from originators.”

Cardinal Health Launches Interactive Map to Help Pharmacists Understand Biosimilar Laws

“Cardinal Health has created an interactive tool that provides pharmacists with key guidance to help them navigate the recent Food and Drug Administration (FDA) approval of the first interchangeable biologic licensed in the U.S. The FDA approval was given to the long-acting insulin called Semglee (insulin glargine-yfgn), which is now designated as a biosimilar for one of the most widely used and costly biologic treatments on the market today – insulin.”

Gold Medal for Gaming Goes to Biosimilars

“Given the time and expense needed to conduct such trials, the prices biosimilar manufacturers set on their products are relatively close to the cost of the branded product. They are priced like branded me-too drugs, not like true generics. The clinical trials needed to win interchangeability status are costlier still. ‘That’s why you don’t see many announced plans to develop interchangeable biologics,’ Simmon said. ‘We’re the only country in the world with a separate standard for interchangeability.’”

Approval of First Interchangeable Biosimilar, Semglee, Is Sign of an Improving U.S. Biosimilars Market, Despite Challenges

“On July 28th, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. There is no clinically meaningful difference between Semglee and its reference product Lantus (insulin glargine). This will usher in more competition, specifically in the insulin glargine market. In turn, it could signal a brighter future for U.S. biosimilars overall. Nonetheless, market and legal hurdles remain, which could prevent biosimilars from reaching their full potential.”

Featured Resources

The Biosimilars Council - Researcher with Tablet

Biosimilar Uptake: The Importance of Healthcare Provider Education

“Multiple factors impact the utilization of biosimilars by healthcare providers and perhaps the best recognized of these is education. This paper discusses the importance of education to biosimilar adoption and lists action-items that various stakeholders in healthcare can adopt to improve the overall understanding of this important class of therapeutics.”

biosimilars are affordable

Competition from Biosimilars Drives Price Reductions for Biologics in the French Single-Payer Health System

“This article measures 2004–20 trends in prices, price reductions, utilization, and market shares for three prominent biologics—Remicade, Enbrel, and Humira—and their eleven competing biosimilars. Biosimilar launches are associated with a sequence of price reductions for the reference biologic, for other biologics that treat similar conditions, and for all related biosimilars. The French experience provides lessons for the US in its efforts to use competition from biosimilars to drive price reductions and savings from biologics.”

Biosimilars Council - Pharmacists working in Pharmacy

Study: Payers Play Wait-and-See Game of Biosimilar Preference

“Most payers tend to adopt a “wait and see” approach to promoting biosimilar switching strategies among providers, according to a focus group study. The approach calls for watching what other payers do rather than initiating switching incentives via policy requirements, according to payers who participated in the study. However, the payers agreed that getting providers to switch to a new biosimilar requires careful market preparation that targets physicians, health systems, pharmacists, and patients.”


GRx+Biosims 2021 – November 8-10 | Virtual Conference

GRx+Biosims is the premier scientific and regulatory event for the U.S. generics and biosimilars industry, featuring timely programming relevant to technical, regulatory and policy professionals. Hear from FDA Acting Commissioner Dr. Janet Woodcock and other FDA officials including Donald Ashley and Drs. Jacqueline Corrigan-Curay, Elizabeth Miller, Sally Choe, Michael Kopcha, 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. Take advantage of the early bird special and register today!

Second Annual IGBA Global Biosimilars Week: Advancing Access – November 1-5, 2021

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 biosimilars content in your own social media channels using daily themes and the hashtag #globalbiosimilarsweek. Learn more.

Want to hear directly from Executive Director Christine Simmon?

Follow her on Twitter @CSimmon_DC.

Interested in joining the Biosimilars Council?

Contact Jewel Smith ([email protected]) 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.