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Australia praised after rejecting biologic suffix

Executive Summary

Adecision by Australia’s Therapeutic Goods Administration (TGA) to not use specific identifier suffixes as part of naming conventions for biologics has been welcomed by the global generics and biosimilars industry. Following a stakeholder consultation, the TGA said it had decided to “maintain the existing naming convention for biological and biosimilar medicines – that is continue using the Australian biological name, without a specific identifier suffix – and strengthen our adverse event reporting”.

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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.

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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