Suffix to distinguish biosimilars now

Designed with an objective to prevent inadvertent substitution of non-interchangeable products and, to make it easier to monitor and track usage once the products are on the market, the new name of the generic drug would be followed by a unique suffix composed of four lowercase letters with no meaning.

The FDA is proposing that original biologic products and their biosimilars share a core drug substance name. The agency is seeking public comment as to whether a distinct suffix should be required for products considered interchangeable with the reference version. A product approved as interchangeable may be substituted for the reference product at the pharmacy counter, as reported by Reuters.

A spokesman for the Generic Pharmaceutical Association, Steve Arnoff, said the organization is studying the FDA's proposal and did not have an immediate comment.

The FDA has only approved one biosimilar - Novartis AG's Zarxio, or filgrastim-sndz. The drug is similar to Amgen Inc's Neupogen, or filgrastim, which is used to reduce the incidence of infection in patients taking certain cancer drugs.