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IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes

Executive Summary

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.

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Taking Biosimilars ‘To The Next Level’

The IGBA wants to take discussions around streamlining biosimilar development to “the next level”, the association tells Generics Bulletin.

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.

FDA Sticks To Its Guns On Biosimilar Naming

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

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