Biosimilars Bulletin | November 2022

Friday December 2, 2022

A Note from Biosimilars Council Executive Director Craig Burton

First, thank you to all whose attendance and engagement made GRx+Biosims 2022 an insightful event. It was great to be in-person and hear from leaders in government and industry. The biosimilars community is in a better position moving forward because of these important conversations.

In particular, the Biosimilars Council thanks Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs within the FDA’s Center for Drug Evaluation and Research, and Dr. Meena Seshamani, Deputy Administrator and Director of the Center for Medicare, for meeting with Biosimilar Council members to discuss efforts to encourage biosimilar competition.

Building on the success of GRx+Biosims 2022, biosimilar stakeholders across the globe came together for the International Global Biosimilar and Generic Medicines Association’s (IGBA) 3rd Annual Global Biosimilars Week. During this social media campaign, stakeholders raised awareness of the powerful impact of biosimilars. Thank you to all who participated. The Biosimilars Council is proud to have contributed to two testimonials used throughout the week:

  • Eileen, a musical theater enthusiast in New York City who is diagnosed with Crohn’s Disease, participated in a Q&A session discussing the impact that biosimilars have had on her life; and
  • Hillel Cohen, Executive Director of Scientific Affairs at Sandoz Pharmaceuticals, joined Biosimilars Council Director Steve Selde to discuss the value of biosimilar education.

Additionally, IQVIA published a must-read white paper examining the market dynamics that will influence patient access to and adoption of pharmacy-benefit biosimilars. The analysis powerfully illustrates the preference of health plans and PBMs for higher priced, high rebate drugs rather than lower list prices, and how this impacts the opportunity for patients to save.

The Biosimilars Council will continue its work to minimize roadblocks to patient access like these and is grateful for all the support and engagement throughout November.

Craig Burton

News & Updates

GRx+Biosims 2022 Conference Recap

Earlier this month, AAM and the Biosimilars Council hosted guests in North Bethesda, Maryland for the 2022 GRx+Biosims Conference. This conference proved to be an unparalleled opportunity for biosimilars professionals to engage with regulators and industry experts, gain new insights on biosimilars regulatory issues, learn about the latest innovations and technical advances, and network with other industry leaders.

Senator Aims to Cut Biosimilar ‘Red Tape’ with Proposal to Eliminate Interchangeable Status

Last week, Sen. Mike Lee (R-Utah) introduced a proposal in Congress that would put an end to switching studies and, in effect, make all approved biosimilars interchangeable. The goal of the Biosimilar Elimination Red Tape Act is to speed access to biosimilars, the senator said in a statement.

AAM’s Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?

This year, the federal government in the United States has done a lot to get new policies passed that will improve biosimilar uptake and lower drug prices as a result. These actions include the implementation of the Biosimilars User Fee Act of 2022 (BsUFA III) and the Inflation Reduction Act, workshops and investigations, and a public commitment to investing in biotechnology.

FDA Officials Discuss Biosimilar Inspections, BsUFA Enhancements

A US Food and Drug Administration (FDA) official [Dr. Sarah Yim] said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as these products are relatively new and involve novel manufacturing processes. She also noted that the facilities making these products are generally new to biosimilar manufacturing.

Featured Resources


Lessons from Semglee: Early Perspectives on Pharmacy Biosimilars

Nearly all of the launched biosimilars are physician administered products and have buy-and-bill dynamics at play. As of 2022, the only biosimilar medications managed through the pharmacy benefit have been limited to insulins, however, that will soon change when one of the largest brands in the history of pharmaceuticals – Humira – faces biosimilar adalimumab competition in January 2023. Download this white paper to learn more.

IGBA Starts Biosimilars Week with New White Paper

The IGBA Biosimilars Committee’s new white paper, “Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline,” further elaborates on one of the four key areas identified in the IGBA’s 2021 Biosimilar medicines Access Policy Blueprint, namely enhancing regulatory efficiencies for greater access.


GRx+Biosims 2022 

GRx+Biosims 2022 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 2022 

The International Generics and Biosimilars Medicines Association (IGBA) is hosting its third annual Global Biosimilars Week. This event raises awareness of the powerful impact of biosimilar medicines and provide key resources for advocates and interested parties. This year’s theme is, “Strengthening Healthcare – the Value of Biosimilar Medicines.” Learn More and download the social toolkit.

Access! 2023 – AAM Annual Meeting

Save the Date! Meet the leaders and decision-makers who are shaping the future of generics and biosimilars. Be inspired by new experiences, real talk and fresh ideas during a period of intense challenges and exciting promise. Join generic and biosimilar industry professionals at Access! 2023. Learn more.

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn

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.