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Bio Relief: US FDA Rules On Biosimilars Naming


The suspense is over: the US Food and Drug Administration (FDA) has made their decision.

As more biologics come off patent in the next few years, the opportunities for biosimilars and the impact upon the biotech and pharmaceutical industries are limitless. While it's exciting for physicians, patients, and payers, the US Food and Drug Administration's (FDA) regulatory ruling on biosimilar suffixes has increasingly taken on more urgency. Well, the wait is now over.

The FDA has determined that a suffix will help distinguish biosimilar products and avoid a substitution mistake--and it has has already included four additional letters on the end of each non-proprietory name for existing biosimilars: Filgrastim, the biologic drug Neupogen, becomes filgrastim-sndz, biosimilar Zarxio. Adalimumab (Humira) becomes adalimumab-atto (Amjevita).

At this point, only four biosimilar drugs are approved in the US, but are not considered interchangeable with their reference biologic. This means pharmacists cannot make a choice whether to give a patient a biosimilar as opposed to a biologic, which is a regular practice with generics and small-molecule drugs.

The new guidance says each suffix can not have a specific meaning attached to it and must include four lowercase letters.

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