Biosimilars Bulletin | March 2022

Wednesday April 13, 2022

A Note from Biosimilars Council Executive Director Christine Simmon

As we close out Women’s History Month, I would like to extend my sincere gratitude to all the women who have helped grow our industry, many of whom we showcased in our #GRxBiosimsWomen social media campaign. Your tireless efforts have made an invaluable contribution to biosimilar adoption and more affordable drug pricing. I am proud to call many of you both my colleagues and my friends, and I look forward to the path ahead as we work to continue expanding access to biosimilar medicines.

This month the Biosimilars Council was encouraged that Congress began the process to reauthorize BsUFA. We look forward to working with policymakers and regulators to modernize the biosimilar review process and set the stage for greater access to lower-cost options for patients.

Finally, AAM’s VP of Policy Craig Burton represented the Biosimilars Council at the Festival of Biologics in San Diego. Craig spoke on the opening keynote panel, and highlighted policy options to increase biosimilar adoption.

With all that took place this past month, I was once again reminded how fortunate we are to work in the biosimilars industry for a cause that is leaving a positive impact on our health care system and for the patients relying on these life-saving medicines.

– Christine

News & Updates

Industry Seeks Clean User Fee Reauthorization as Lawmakers Eye Riders

David Gaugh, senior vice president for sciences and regulatory affairs at AAM, said the group and its Biosimilar Council “strongly support timely congressional reauthorization of the user fee agreements.” He added that the Generic Drug User Fee Amendments (GDUFA III) and the Biosimilar User Fee Amendments (BsUFA III) “are the culmination of months of negotiation, have been subject to public review and comment and represent a careful balance between all stakeholders.”

Expert: ‘Pharmacists Should Have a Role at the Table’ When Payer or Drug Availability Challenges Arise

Pharmacy Times interviewed Shannon Hough, director of ClinReview in Clinical Content for McKesson, on the growing shift to biosimilars in oncology, which is impacting patients and practices by reducing the financial burden of oncology treatments and increasing access to therapies, resulting in greater medication adherence.

Drug Pricing Reforms Should Focus on Expanding Choice, Not Imposing More Government Controls

Competitors to originator biologics exist (i.e., biosimilars) that are just as clinically efficacious and 40% to 60% less expensive than the originators. However, far too many drug formularies place biosimilars on worse tiers, denying patients the opportunity to use these medicines. As a result, the formulary restrictions reduce patient choice and force patients to pay higher costs.

BsUFA Reauthorization and Modernization Is the Key to a Healthy Biosimilar Market

The Biosimilar User Fee Act, or BsUFA, will include a commitment by biosimilar manufacturers to pay fees that support the FDA’s review of biosimilars, as well as other regulatory activities. For example, BsUFA fees accounted for 60% of total program costs in 2020, and it is critical that a reauthorization is signed into law before the end of the year, when the current funding agreement expires.

Drug Pricing Woes Linger as Medicare Mulls Point-of-Sale Changes

Manufacturer rebates “artificially increase the negotiated price of drugs in the Medicare program,” Christine Simmon, senior vice president of policy and strategic alliances at the Association for Accessible Medicines, told the Medicare agency. The proposal is a step in the right direction, but “additional work remains to remove harmful distortions in the Part D Program,” Simmon wrote in a comment letter.

Roy Fleischmann, MD: History and Implementation of Biosimilars in Rheumatology

As a part of our biosimilars series, Rheumatology Network interviewed Roy Fleischmann, MD, to discuss the history of biosimilars as well as his thoughts on implementing biosimilars in the United States. Fleischmann is Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas.

Featured Resources

Improved Biosimilar Uptake Saved US Health System $26.9M Over 2 Years 

Providence St. Joseph Health, a nonprofit health system based on Seattle, Washington, was successfully able to encourage the use of biosimilars instead of the originator biologics through the use of several tools, which saved the system $26.9 million over 2 years. There were 7 components to the biosimilar adoption utilization management program initiatives, as reported by Sophia Z. Humphreys, PharmD, MBA, director of system pharmacy clinical services for Providence St. Joseph Health.

Biosimilar development

Implementing and Optimizing Biosimilar Use at Mayo Clinic

Creation of a multidisciplinary team to implement formulary-preferred contracted biosimilars led to the adoption of biosimilars throughout Mayo Clinic with considerable pharmaceutical line-item savings. In the final postimplementation period, the absolute percentage increase of formulary-preferred biosimilars was 69% for bevacizumab, 63% for epoetin alfa, 80% for filgrastim, 79% for rituximab, and 72% for trastuzumab. Pharmaceutical line-item savings in the 12-month postimplementation period totaled $23.1 million across all 5 biologics.

Employers Highlight Barriers to Biosimilar Adoption

The promise of large savings due to the use of biosimilars has been stymied by barriers to adoption; however, there are actions employers can take to overcome these obstacles, according to a report based on a series of roundtables with employers. The National Alliance of Healthcare Purchaser Coalitions (National Alliance) brought together 7 regional coalitions and more than 60 employers and compiled the findings and recommendations in the Improving Drug Management: Employer Strategies on Biosimilars report.

How the U.S. Compares to Europe on Biosimilar Approvals and Products in the Pipeline

Global sales for the top ten branded biologic drugs totaled approximately $85 billion in 2020. In a September 2020 report, the IQVIA Institute for Human Data Science estimated biosimilar sales totaling $80 billion over the next five years compared to $14 billion during the previous five years (2015-2019), and that the availability and use of biosimilar medicines would reduce U.S. drug costs by $100 billion through 2024.

Patient Perspectives

Treating Ulcerative Colitis, and Enjoying a Slice or Two

Greg, 37, of Los Angeles, CA., spends most of his time hiking, running and lifting weights, but his greatest passion in life is pizza. Not long ago, he made a bet with his wife that he could eat pizza and nothing but pizza for 45 days. As if that weren’t unusual enough, you should know that Greg has a history of ulcerative colitis.

Singing, Dancing and Taking Care of Herself with Biosimilars

Eileen, 28, lives in New York City and is pursuing her dream of a career in musical theater. Her stage credits keep growing, and thanks to her biosimilar medication, her Crohn’s disease isn’t getting in the way.


GRx+Biosims 2022 – November 7-9, 2022

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. Register Now.

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.

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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.