FDA recommends adding suffixes to name biosimilars

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products.”

The draft guidance describes the current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.

The agency declares, their current thinking is that shared nonproprietary names are not appropriate for all biological products. 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.

Accordingly, for biological products, FDA intends 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. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix.

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. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.

In a blog post, FDA officials said the agency must consider what to do to address previously approved biologic products that do not have a suffix and is seeking public comment on the matter. In the meantime it is proposing designating names that contain a suffix for six previously licensed biologic products.

The draft guidance can be found here. This long battle seems to continue as innovators and biosimilar developers will try to find the best way to change the market before the launch of  several biosimilars in the US in the near future.