FDA to alter biosimilar ‘suffix’ policy
The US Food and Drug Administration (FDA) yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
According to a statement issued by FDA commissioner Scott Gottlieb yesterday, March 7, the FDA will change the designated suffixes added to the end of the name of a biosimilar drug.
The agency will also abandon its policy of renaming previously-licensed drugs to bring them in line with the naming convention applied to new products. Under the revised rules, the convention will not apply at all to existing products which are being converted to biosimilar status.
The FDA issued a guidance document in January 2017 outlining a policy of using a distinguishing suffix at the end of both a biosimilar and an originating product’s non-proprietary names.
In the statement, issued yesterday March 7, Gottlieb said that he favoured the use of a suffix at the end of a biosimilar’s name as it improved patient safety. He noted that critics of the policy had expressed concerns that it could inhibit biosimilar competition because the inclusion of a suffix at the end of the name could give the impression that products were inferior.
The FDA’s January 2017 policy applied the use of a suffix to both biosimilars and the originating products, which Gottlieb said achieved a balance in promoting both pharmacovigilance and biosimilar competition.
The agency has now revised the policy, announcing that it no longer intends to modify the proper names of biological products which have already been licensed without a suffix in their name.
The FDA will also adopt a new convention for the suffixes added to the end of newly licensed drugs. These products will now be given a name which is “a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters”.
Previously, the convention was to separate the name and the suffix with a hyphen.
In the statement, Gottlieb noted that stakeholders had warned that the policy of renaming already-licensed drugs would impose a significant cost on manufacturers.
“The FDA has determined that the crucial public health goals of the naming policy could still be accomplished by applying the naming convention to newly-licensed biological products, while avoiding the negative consequences raised by extending the naming convention to previously-licensed products”, the statement said.
Late last year, the FDA announced a new program that would allow certain drugs to “transition” to biosimilar status, including insulin. The guidance published yesterday clarified that the biosimilar naming convention will not be applied to these products.
Gottlieb will not be in the job for much longer, having announced this week that he intends to step down from his post as commissioner within a month.
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