The U.S. FDA has released a guidance regarding naming of biologics and biosimilars. Under the Public Health Service Act, biologics must bear a nonproprietary name with an FDA-designated suffice. The Agency believes that shared nonproprietary names are not appropriate for all biologics. To ensure clear identification of biologics for the purposes of pharmacovigilance and to differentiate biologics that are not interchangeable, the Agency proposes that the suffix for biologics comprises four lowercase letters based on the nonproprietary name of the product.
As far as interchangeable products, i.e., biosimilars, the Agency is still considering whether the suffix should be unique or share the same suffix as the reference product.
Comments are due Oct. 27.