FDA official issues warning about looming biosimilar void

BETHESDA, MD — The US Food and Drug Administration’s (FDA) top biosimilar regulator said that a recent report that found lacking biosimilar development to many of the biological products that will soon lose patent protection is a warning sign for the future of drug affordability in the US.

Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) within the Center for Drug Evaluation and Research (CDER), indicated that her office is looking to streamline reviews of biosimilars, so they are more like those for generic drugs, during a presentation at the Association of Accessible Medicines (AAM) GRx+Biosim meeting on 28 October.

Moderator Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at AAM, asked Yim about the agency’s effort to streamline biosimilar reviews and a recent IQVIA report on the looming “biosimilar void” in the US.

The report, published in February 2025, finds that between 2025 and 2034, 118 brand-name biologic medicines will lose their patent protections, creating a market opportunity valued at approximately $234 billion. However, as of mid-2024, biosimilars to just 12 of those products were in active development, leaving 106 with expiring patents that may face little or no competition.

“I think that it’s kind of a warning sign to us that we need to be as efficient as possible to make it feasible economically for biosimilar developers to develop some of these other biologics that maybe are not the Humiras of the world. That goes along with our public health mission, we want to try to increase access for as many people to these biologics,” Yim said.

AbbVie’s Humira (adalimumab) is an injectable medication used to treat several autoimmune conditions, including rheumatoid arthritis, and was once the top selling drug worldwide. Humira was first approved in the US in 2002 and saw its first biosimilar competitor approved by FDA in 2016, though it did not launch until 2023. There are now 10 FDA-approved biosimilars to Humira, including three that are interchangeable.

Yim stated that the division aims to update and streamline the biosimilar review process to align it more closely with the review processes for generic drugs. She made this comment after Randazzo requested her to discuss the key takeaways from the FDA’s workshop on interchangeability held in September 2025.

Yim noted that Center for Drug Evaluations and Research (CDER) director George Tidmarsh’s remarks at the workshop indicated his willingness to streamline reviews for biosimilar drugs, aligning them more closely with reviews of generic drugs.

“He clearly thinks that we are ready to streamline [biosimilar reviews]. He even went so far as to talk about biosimilars being more like generics. Which I thought was fascinating, I think it was kind of like marching orders for us, but we are already marching in that direction. That was my takeaway from the workshop. If we want to streamline, we will get that support from CDER,” she said.

When asked about upcoming priorities and what to expect next year, Yim stated that her office is working on providing input for the upcoming multidisciplinary guideline from the International Council on Harmonisation (ICH). This guideline will introduce a new framework for assessing the utility of comparative efficacy studies in biosimilar development programs. This topic represents a new area of focus for harmonization.

FDA official issues warning about looming biosimilar void

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