FTC Warns FDA That Biologic Suffixes Will Curb Competition
Executive Summary
The US Food and Drug Administration should abandon its suffix-based naming proposals for biosimilars, according to local competition regulator the Federal Trade Commission, citing a dampening effect on the market and the likelihood of confusion.
You may also be interested in...
FDA Is Urged To Make All Biosimilar Insulins Interchangeable
As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.
FDA Biosimilars Acting Director Yim Is ‘Not A Great Fan’ Of Suffix-Based Naming Policy
Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.
IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes
In the second of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on worldwide issues around biosimilars, particularly naming conventions.