US Must Rethink Biologic Naming Suffix, Says IGBA
In the wake of a decision by Health Canada not to implement a suffix to non-proprietary names to distinguish biosimilars from their branded counterparts, the IGBA has urged the FDA to reconsider the US approach.
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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.
A citizen petition filed by biosimilars industry veteran Sarfaraz Niazi has once again urged the FDA to reconsider its approach on biosimilar naming, along with suggesting changes to language used by the regulator to describe biosimilars.
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.