Biosimilars Bulletin | February 2023

Tuesday March 7, 2023

A Note from Biosimilars Council Executive Director Craig Burton

Thank you to everyone who attended Access! 2023 and helped make the event a success. We were honored to be joined by Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, who detailed his interest in making the pharmaceutical value chain more transparent and ensuring that lower cost biosimilars and generics can reach more patients. The event included extensive discussion of the state and future of the biosimilars market, including what is needed for a sustainable market over the long run. For instance, Michael Kleinrock, Research Director at the IQVIA Institute, noted his enthusiasm about the potential for biosimilars while noting there are “[…] some things to be desired in terms of the volume penetration in the market, the cost savings for different stakeholders.”

And there was extensive discussion about the role of rebates. EmsanaRx Co-Founder and CEO Greg Baker highlighted the issue: “Drug affordability in America is a problem because PBMs sit in the middle and try to make more money this year than they made last year, and then they’re going to have to make more money next year and the year after and the year after.” Brenda Motheral, CEO of Archimedes, echoed this sentiment: “We’ve already seen Cigna speak to how their earnings are going to grow, specifically due to the growing rebates around this product [Humira].” If you missed it, we hope you’ll mark your calendars to attend Access! next year, February 5-7 in Tampa, Florida.

Building on this, be sure to read our recent blog that outlines how these medicines will benefit patients and provide savings but why it will take time for savings to grow. The blog is in response to an insightful report from Alex Brill and Christy Robinson of Matrix Global Advisors on the unique challenges of this market, “Near-Term Expectations for Adalimumab Biosimilars in the United States.”

Thank you again to all who attended Access! 2023. I am looking forward to seeing many of you at the Festival of Biologics in San Diego in a few weeks. The Biosimilars Council is a partner of this event, and if you have not already registered, you can do so here.

Craig Burton

News & Updates

Gastroenterologists, Rheumatologists Cite Greatest Familiarity With Biosimilars

The report noted a growing familiarity of biosimilars among rheumatologists, with 76% now saying they are very familiar with these products, compared with 56% in a report released June 2022. Only gastroenterologists reported being more familiar, with 81% saying they were very familiar with biosimilars. Ophthalmologists and dermatologists were much farther behind, with only 33% and 31%, respectively, saying they were very familiar.

Humira Biosimilars: Ending a Monopoly, but Savings Will Take Time

The biosimilars market has reached a new milestone, with the first-ever biosimilar to Humira (adalimumab) recently launching, and as many as eight more expected later in 2023. This is the bestselling drug in the U.S., and the introduction of biosimilar competition represents a major expansion in patient access to treatment and savings. However, new research shows that stakeholders will need to be patient while the benefits of adalimumab biosimilars materialize.

More Biosimilars Are Coming, But Don’t Expect Instant Savings

The presence of biosimilars and the way the pharmacy benefit design is set up allows PBMs and insurers to leverage market competition and negotiate steeper rebates that are never passed back to the patient at the point of sale.

PBMs may sometimes pass back some of the savings to the insurer. Still, due to consolidation in the past years, the insurers and PBMs are the same; the savings or profiteering stays within the insurer/PBM conglomeration.

Paving the way for biosimilars: The FDA’s Biosimilar User Fee Amendments III (BsUFA III)

The BsUFA III (FY 2023 to 2027) continues to work towards effective scientific coordination and review consistency, with a renewed focus on efficient governance of the biosimilar biological product review program. The Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs’ (OND’s) Office of Therapeutic Biologics and Biosimilars (OTBB) Director, Dr Sarah Yim, has said that some important areas of work under BsUFA III would be the development of guidance around product presentation and container systems, labeling considerations for interchangeable biosimilars, and tools for assessment of manufacturing facilities.

The Warped Incentives Behind Amgen’s Humira Biosimilar Pricing – And What We Can Learn From Semglee and Repatha

Unfortunately, we should expect most PBMs and plan sponsors to embrace the high-list/high-rebate version. The plans that adopt the higher-priced biosimilar will get bigger rebates, while patients with coinsurance and deductibles end up paying more out-of-pocket.

Featured Resources

Cardinal Health 2023 Biosimilars Report

2023 Biosimilars Report

Surveying more than 350 providers across rheumatology, ophthalmology, gastroenterology and dermatology, this report offers new analysis, insights into market growth, drivers of adoption and obstacles that remain. With an updated analysis of biosimilar market adoption and key milestones achieved throughout 2022, Cardinal Health experts discuss how policy and updated formulary announcements may impact patient access to these critical therapeutics.

Matrix Global Advisors Adalimumab Report

Near-Term Expectations for Adalimumab Biosimilars in the United States

The first US adalimumab biosimilar, Amgen’s Amjevita, launched on January 31, 2023. Over the remainder of the year, as many as eight more biosimilars are set to enter the US market, where AbbVie, the reference product manufacturer, derives more than 87 percent of its global Humira revenues (AbbVie, 2023). This paper explores this long-awaited moment and the expected transition from a monopolistic adalimumab market to a competitive marketplace with multiple biosimilars.

Events

Festival of Biologics – March 20-23, 2023 (San Diego, CA)

This year, AAM and its Biosimilars Council are official partners of the Festival of Biologics! This event, held in San Diego, California, gives you the opportunity to share research, create new partnerships, and tackle the clinical trials, manufacturing and commercial challenges involved in bringing new therapies to market. Register now!

GRx+Biosims 2023 – October 2-4, 2023 (North Bethesda, MD)

GRx+Biosims 2023 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. Learn more.

Global Biosimilars Week – November 13-17 (Virtual)

The goal of this social media campaign is to raise awareness of the powerful impact of biosimilar medicines and provide key resources for advocates and interested parties. All week, we invite stakeholders, patients, health care professionals and their organizations around the world to share their resources and information about biosimilar medicines in social media with the hashtag #GlobalBiosimilarsWeek. Learn More.

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn

Interested in joining the Biosimilars Council?

Contact Jewel Smith (jewel.smith@accessiblemeds.org) 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.