Updated draft guidance released by the US Food and Drug Administration (FDA) in March 2019 on naming conventions for biologics and biosimilars has provoked a strong pushback from the local and global biosimilars industry.
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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