FTC Warns FDA That Biologic Suffixes Will Curb Competition
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.
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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.
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.