FDA proposes naming system for biosimilars


Draft guidance from the FDA on the naming of biosimilars recommends the generic name is retained with four random letters added at the end to provide a unique identifier.

“Our current thinking is that shared nonproprietary names are not appropriate for all biological products,” the FDA said in a statement.

“There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable,” it said.

For biological products we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. 

However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product.

The draft guidelines have won the support of the ACR, with Douglas W. White chair of the ACR’s Committee on Rheumatologic Care stating: “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving.”

For a copy of the draft guidance click here. 

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