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1 September 2015Americas

FDA wants suffixes to distinguish biosimilars from biologics

The US Food and Drug Administration (FDA) has proposed using four-letter suffixes to name biosimilar drugs.

Published on Friday, August 28, its guidance attempts to clarify the naming rules for such drugs, which are similar versions of original biologic products.

“Our current thinking is that shared non-proprietary 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 added.

According to the FDA’s guidance, an original drug and the biosimilar will share a drug compound name but will be distinguished by the use of an FDA-designated suffix that is unique to each product.

“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,” the FDA said.

In March this year, LSIPR reported that the FDA had approved Sandoz’s cancer product Zarxio—the first biosimilar to be rubber stamped in the US.

Zarxio is a biosimilar version of Amgen’s Neupogen (filgrastim), an injection that helps to reduce the risk of infection in cancer patients receiving chemotherapy.

At the time the FDA described filgrastim-sndz as a placeholder non-proprietary name for Zarxio, though it said this should not be viewed as a decision on a comprehensive naming policy for biosimilar and other biological products.

The FDA is seeking responses to its proposals by October 27.

“We invite comment on the draft guidance, including potential approaches for designating and incorporating suffixes retrospectively and prospectively into the nonproprietary names of all biological products,” the FDA said.