The FDA has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes.
Since 2015, the FDA has been adding the meaningless suffixes to biosimilars’ nonproprietary names as part of an effort to improve pharmacovigilance. And since November 2017, the agency also began adding the suffixes to newly approved biologics’ names, with the intention of going back and adding suffixes to all biologics’ nonproprietary names.
Currently, all 17 approved biosimilars have been approved with the four-letter suffixes, as have the proper names of 27 originator biologics.
But now, according to draft guidance released Thursday, the FDA says that the nonproprietary names of previously approved products “need not be revised in order to accomplish the objectives of the naming convention.” The FDA in January 2017 published its final guidance on how the suffixes would be added.
The objectives from that plan — “pharmacovigilance and safe use” — can be accomplished, the FDA says, by applying the naming convention to biological products “at the time they are licensed” and “without applying it to licensed biological products that do not contain a suffix in their proper names.”
So why is the FDA deciding not to go back and rename biologics with the suffixes?
“This approach is intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients, given that the nonproprietary names of drugs seldom change postapproval,” the draft guidance says.
But the guidance will also mean that all biosimilars will have random nonsense suffixes, while their reference products will not have the suffixes — potentially raising questions about whether the products are similar.
The Biosimilars Forum said in a statement that the FDA’s “decision abandons the retrospective addition of a suffix to origination biologics, leading to an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars.”
FDA Commissioner Scott Gottlieb said in a statement: “We expect that as time goes on, and more biological products are introduced to the market with distinguishable suffixes, patients and providers increasingly will understand that the suffixes reflect a consistent naming convention and are not an indicator of product quality.”
And for interchangeable products, the draft guidance says unique suffixes will be used to “facilitate manufacturer-specific pharmacovigilance.”
“An applicant for a proposed interchangeable product submitted under section 351(k) of the PHS Act should propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure. Such submissions can be made during the investigational new drug application (IND) phase or at the time of BLA submission. An applicant should submit up to 10 proposed suffixes, as described in the Naming Guidance, in the order of the applicant’s preference,” the draft says.
But the FDA also says that it “does not intend to apply the naming convention described in the Naming Guidance to transition biological products.”
Similarly, the FDA is “reconsidering whether vaccines should be within the scope of the naming convention.” Sanofi wrote to the FDA last month explaining how the addition of suffixes to vaccine labels could cause confusion among health care providers and negatively impact public health.
“In view of the existing framework for ensuring safety reporting and monitoring for vaccines, the agency is carefully considering whether the information that’s already available to us through identification systems associated with the administration of vaccines is sufficiently robust for ensuring pharmacovigilance such that we may not need distinguishable proper names with suffixes for vaccines,” Gottlieb added.
The FDA’s use of the nonsense suffixes is also unique in that no other country in the world has employed their use. Canada recently decided to not use suffixes in the non-proprietary names of biologics or biosimilars.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.
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