Biosimilars Forum Applauds FDA’s Approval of Second Interchangeable Biosimilar

Meaghan Rose Smith, executive director of the Biosimilars Forum, released the following statement after the U.S. Food and Drug Administration (FDA) awarded an interchangeable designation to the biosimilar Cyltezo. Cyltezo is the second biosimilar to receive an interchangeable designation and the first interchangeable biosimilar for the reference product Humira.

“The Biosimilars Forum applauds the FDA’s decision to approve the first interchangeable biosimilar for Humira. Interchangeable biosimilars pave the way for substitution of safe and effective biosimilars for biologics. The approval of more biosimilars is key for expanding access, increasing competition and lowering costs for prescriptions in America.

“The Biosimilars Forum looks forward to continuing to serve as a voice for patients and to work with the FDA and policymakers to advocate for commonsense policy solutions to give more patients access to lifesaving, lower-cost biosimilars. Biosimilars, which cost on average 30 percent less than reference biologics, are a solution to affordability challenges faced by millions of Americans.”

The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a new report and interactive savings tool highlighting projected state savings for patients, taxpayers, and employers associated with a 75 percent adoption rate of biosimilars, which could result from commonsense, bipartisan policy changes. The report found that Californians could save more than $1 billion annually with a 75 percent biosimilar market share. Similarly, Floridians could save more than $960 million, and Texans and New Yorkers could save more than $820 million.

For more information on the Biosimilars Forum, visit