Skip to main content
 

The Biosimilars Forum Disagrees with the Food and Drug Administration’s Decision on Naming of Biologic Medicines

The Biosimilars Forum released the following statement:

“Today’s announcement by the FDA is a direct blow to biosimilars uptake in the U.S. The decision abandons the retrospective addition of a suffix to origination biologics, leading to an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars. This decision will disincentivize biosimilar uptake at a time when the government should be implementing policies that incentivize the use of biosimilars, as they are one solution to help attack rising healthcare costs. Biosimilars are proven to be as safe as and effective as the reference product, and could save the U.S. 54 billion dollars in healthcare costs over the next decade. To realize this saving it will require strong policies to create a more competitive marketplace leading to increased uptake of these lower cost, life-saving treatments.”

Date

Thursday, March 7, 2019 - 2:30pm