Biosimilar Council comments on IQVIA report on biosimilar void

AAM said the report highlights that 90% of the brand biologics scheduled to lose exclusivity in the next 10 years do not have biosimilars in development.

Sandra Levy

2/12/2025

The Biosimilar Council commented on a report released by the IQVIA Institute, Assessing the Biosimilar Void in the U.S., highlighting a crisis in the lack of development in biosimilar for currently available biologic medicines.

“Biosimilars are making more therapies more available for America’s patients, but too many government policies are slowing biosimilar development and adoption,” said Craig Burton, executive director of the Biosimilars Council. “Today’s report highlights the harm – 90% of the brand biologics scheduled to lose exclusivity in the next 10 years do not have biosimilars in development. The ‘biosimilar void’ in the U.S. threatens patient access to lower cost treatments. Policymakers must take concerted action to encourage biosimilar development through streamlining FDA processes, ending patent thickets, ensuring rapid PBM adoption, stabilizing provider reimbursement and ending the misguided IRA price controls that undermine biosimilar investment.”

The Biosimilars Council published a blog on the biosimilar void highlighting that 118 biologics will lose patent protection between 2025 and 2034, representing a $234 billion market opportunity. But as of today, only 12 of these medicines have biosimilars in development.

Since the first biosimilar launched in 2015, these lower-cost medicines have saved the healthcare system nearly $36 billion. These savings were supposed to continue growing as more biosimilars entered the market. Instead, we’re seeing a slowdown in biosimilar development, an uneven playing field that discourages competition, and a policy, regulatory and reimbursement landscape that makes it harder—not easier—for biosimilars to gain traction, the Council said.

The Council recommends several policy and regulatory steps to accelerate biosimilar development and patient savings: eliminate unnecessary regulatory barriers; fix patent abuse and market delays; curb the abuse of the patent system; ensure fair market access; plans should cover biosimilars at launch; and reverse the damage done by the Inflation Reduction Act.