Biosimilars Bulletin | February 2022

A Note from Biosimilars Council Executive Director Christine Simmon

Happily, members of the Biosimilars Council and AAM were able to come together in-person for Access! 2022 in Orlando. It was a joy to catch up with old friends and colleagues, and I would like to extend my sincere gratitude to everyone who helped make this conference a success.

At the conference, we debuted our second annual “Voices of Access” report. Patients shared their stories, with Eileen and Greg explaining how biosimilars have improved their lives. Over the three days of our annual meeting, we also heard from industry leaders about the trajectory of the biosimilars industry and strategies to ensure biosimilars continue to reach more patients.

During the session, “Leveraging Biosimilar Competition for Success” I was joined by Steven Allison, PharmD, Vice President of Pharmacy at AdventHealth; Martin Ares, Vice President of Biosimilars and Specialty at Sandoz; Bret Jackson, President of the Economic Alliance for Michigan; and Steve Miller, M.D., Chief Clinical Officer at Cigna, for an in-depth and spirited conversation about the past and potential of the biosimilars industry. Read our recap blog for more on Access! 2022.

I would also like to take this opportunity to congratulate and welcome Dr. Robert Califf as he takes the helm of the U.S. Food and Drug Administration. We look forward to working with the agency throughout the process to reauthorize BsUFA and to ensure that America’s patients continue to have timely access to biosimilars.

Once again, thank you to everyone who traveled to Orlando and made Access! 2022 a success. Continue to follow the Biosimilars Council as we work for greater access through biosimilars adoption. We look forward to seeing you all in-person at GRx+Biosims 2022 on November 7-9 in North Bethesda, Maryland.

– Christine

News & Updates

Access! 2022 Conference Recap

After the opening ceremonies, Biosimilars Council Executive Director Christine Simmon led a roundtable discussion on “Leveraging Biosimilar Competition for Success.” The panelists brought to light the significant success of the biosimilars industry in recent years. With more than 30 FDA approved biosimilars and many more expected to hit the market soon, the industry generated nearly $8 billion in savings for patients in 2020 alone.

Biosimilars: A Rapidly Maturing Market

Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share from originator products.

CMS Seeks Answers for Slower-Than-Expected Biosimilar Adoption, Rawal Says

An official with the Center for Medicare and Medicaid Innovation (CMMI) told leaders from the generic and biosimilars industries that CMS is committed to policies that will expand the use of biosimilars, given the need to make drugs more affordable and “the potentially important role biosimilar adoption may have for the success of our value-based payment models.” Purva Rawal, PhD, senior advisor and chief strategy officer for CMMI, spoke during the Association for Accessible Medicines (AAM) Access! annual meeting, which gathered in Orlando, Florida, February 15-16.

Experts Call for More Regulatory Action to Address Biosimilar Interchangeability Confusion

During the panel discussion at the Association for Accessible Medicines’ (AAM) Access! 2022 Annual Meeting, the speakers dove into how to leverage competition among biosimilars and their reference products to allow for greater access among patients treated with biologic medicines and greater savings for patients and the health care system, according to Christine Simmon, JD, the panel moderator, who is also executive vice president of policy and strategic alliances at the AAM and executive director of the Biosimilars Council.

Lack of Transparency and Misaligned Incentives Reduce Adoption of Biosimilars Per National Alliance of Healthcare Purchaser Coalitions

The adoption of biosimilars (similar to already approved biologic drugs) in the US could save $133 billion over the next four years, but access and adoption barriers may limit these savings. To help employers overcome these obstacles, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) brought together seven regional coalitions and more than 60 employers for a series of roundtables across the country.

Increase Patient Access to Biosimilars in 2022

This will be a unique year because Congress will formalize and advance legislation that includes the reauthorization of the biosimilars user fee agreement, known as BsUFA. Last year, the Biosimilars Council was one of the lead negotiators with the Food and Drug Administration (FDA) throughout a lengthy process that culminated in a performance goals agreement. This serves as the foundation for the BsUFA reauthorization and includes pilot programs for the FDA to explore ways to advance the development of interchangeable biologics and improve the efficiency of biosimilar product development. We look forward to working with Congress to pass and the agency to implement this important legislation.

User Fee Reauthorization Process Kicks Off in Congress

In the first hearing of the House Energy & Commerce health subcommittee in the process to reauthorize the US Food and Drug Administration’s user fee programs for human drugs and biosimilars, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), testified to the success of the agency’s current user fee programs and on the enhancements to those programs the agency seeks.

Biosimilar Medicines Bring New Optimism on RA Awareness Day

On February 2 we marked Rheumatoid Arthritis (RA) Awareness Day and shined a light on the roughly 1.5 million Americans dealing with the disease. This year’s commemoration carried a new significance and reason for optimism. That’s because preparations are underway to ensure that RA patients in the U.S. who take brand-name Humira will finally have access to FDA-approved, more affordable biosimilar versions of their medicine next year.

Featured Resources

Cardinal Health Report Sees 2022 as “Turning Point” for Biosimilars

Use of biosimilars will reach new therapeutic areas and new sites of care in 2022, as the industry prepares for competition with Humira, the top-selling drug in the world—an event that will mark a seismic shift not only in the pharmaceutical marketplace but across health care, according to a new report from Cardinal Health. The year 2022 “is set to be a turning point,” in the United States, as biosimilars are on their way to delivering $133 billion in aggregate savings by 2025, according to “2022 Biosimilars Report: The U.S. Journey and Path Ahead.”

Study: Entities Must Work Together to Increase Use of Biosimilars

The federal government, institutions, medical associations and pharmaceutical companies must work together to address patient and physician concerns about the use of biosimilars in the United States, according to the results of a study published in Seminars in Arthritis and Rheumatism.

Several Cancer Biosimilars Appear Clinically Indistinguishable vs Reference Products

Patients who were treated with cancer biosimilars and underwent extensive clinical evaluations experienced indistinguishable efficacy compared with reference products across drugs, disease types and outcomes, according to results from a systematic review published in JAMA Oncology. Of the 31 biosimilar studies and 3 reference products across 7 subgroups included in the analysis, no differences in surrogacy efficacy were observed compared with the reference drugs.

Events

GRx+Biosims 2022 – November 7-9, 2022 (North Bethesda, Maryland)

GRx+Biosims 2022 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. 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.

Want to hear directly from Executive Director Christine Simmon?

Follow her on Twitter @CSimmon_DC

Interested in joining the Biosimilars Council?

Contact Jewel Smith (jewel.smith@accessiblemeds.org) for more information.