October Biosimilars Bulletin: GRx+Biosims 2023 Recap

Wednesday November 1, 2023

October kicked off with our annual GRx+Biosims conference in North Bethesda, Maryland, bringing together prominent experts and key figures from both the government sector and the generic and biosimilar industries. Over the course of three days, attendees partook in a series of in-depth discussions, presentations and keynote sessions to consider regulatory and policy developments that that will enhance patient access to cost-effective medications.

A highlight of the conference was a fireside chat I had with Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars (OTBB) within the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), FDA. Our conversation explored the pivotal role of regulatory agencies in advancing the development and approval of biosimilars, contributing to greater patient access to vital treatments.

Throughout our exchange, Dr. Yim emphasized the FDA’s collaborative approach in navigating the evolving landscape of biosimilars. She noted “If we really want to get products out there to more people, and more products developed, we have to be more efficient about it.” And on the hot topic of biosimilar interchangeability, she stated that “Scientifically, biosimilars and interchangeables are really not distinguishable. It becomes a source of confusion for people… To try and combat confusion, we wanted to take the focus away from the two designations.” In a blog post published just last week, Dr. Yim reiterated her message around the need to reduce misunderstanding between the two designations, affirming that, “there may be inaccurate perceptions that interchangeable biosimilars are safer or more effective than biosimilars that are not approved as interchangeable. The interchangeability designation does not indicate a higher level of biosimilarity.” You can read Dr. Yim’s full blog here.

Other biosimilar sessions at GRx+Biosims 2023 focused on:

  • Streamlining Biosimilars Development: This excellent panel consisted of FDA and Biosimilars Council members on how we can work with regulatory bodies to streamline biosimilar development.
  • Ask a Regulator: Attendees heard from Health Canada, EMA, Anvisa and FDA representatives about current activities.
  • The Evolving Science of Interchangeability: FDA discussed a new statistical meta-analysis of randomized clinical switching studies and Council members discussed the future of U.S. interchangeability and FDA’s guidances on interchangeability.
  • Post-Approval Changes for Biosimilars: Council members and FDA discussed issues on post-approval changes for biosimilars, including changes to approved applications, reporting of post-approval manufacturing changes, product quality data recommendations, comparability, guidance for industry, as well as examples of changes reported in a PAS.
  • FDA Expectations for Biosimilar Manufacturing Inspections: This session flowed beautifully with the FDA first outlining their expectations of what to expect, and be prepared for, during an inspection followed by industry giving their perspective on how to prepare for FDA inspections.
  • Biosimilars – Keys to Success in the Pharmacy Benefit: This panel discussed adoption trends facing biosimilar versions of Humira and insulin and discussed what manufacturers need to be thinking about to create a sustainable biosimilar marketplace.
  • Biosimilars – Keys to Success in the Medical Benefit: Panelists discussed the state of the market for biosimilars covered under the medical benefit, reflecting on differences in adoption to date and key learnings for achieving future commercial success.

A special thank you to our many presenters and attendees for making this year’s conference successful. These valuable and timely discussions set the stage for our continued work to address the many important issues facing the biosimilars industry.

Looking ahead to November, biosimilar stakeholders across the globe will come together for the , taking place November 13–17. The mission of this online, social media campaign is to raise awareness of the powerful and lifechanging impact of biosimilar medicines. This year’s theme is “Making Cancer Care More Accessible to Patients and Healthcare Systems” and we encourage you all to participate in their live webinar, . This important webinar will focus on the role of policies related to biosimilar medicines, and how stakeholders can collaborate to expand global cancer care.

And finally, as the dust settles around the House Speaker elections this month, the Energy & Commerce Committee’s Subcommittee on Health held a hearing on October 19 that included consideration of Rep. Hudson’s H.R. 1352, the Increasing Access to Biosimilars Act of 2023, which would create a voluntary shared savings biosimilar reimbursement program in Medicare. The bill would reward new provider adoption of biosimilars, which in turn would expand patient access and return meaningful savings to taxpayers. We look forward to working with the committee to enhance patient access to biosimilars. You can read our letter of support for H.R. 1352 .


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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.