Express Scripts to FDA: Hold Off on Biosimilar Naming Decisions for Now

November 30, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

FDA should not release naming rules for biosimilars ahead of interchangeability guidelines, says the pharmacy benefit manager.


While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

Express Scripts wrote in a letter to FDA dated Nov. 19, 2015 that it urges the agency “to delay finalizing any nomenclature system for biosimilars excepting those products already approved-until such time that it is ready also to propose its interchangeability standards” and that “only a comprehensive approach that considers both interchangeabilty standards along with how to distinguish them via nomenclature can more effectively mitigate the need for potentially painful and disruptive changes to either standard, or both, in the future.” For a drug to be considered for interchangeability, the sponsor has to indicate that it is filing for this type of status following a biosimilar application. Sandoz, which was granted the first biosimilar approval by FDA for Zarxio (filgrastim), did not apply for its version of filgrastim to have an interchangeability designation.

All of the stakeholders seem to agree, however, that retrospective alteration of a drug’s name after it has achieved interchangeability should not occur. Thus, even if a drug is considered interchangeable, its name should not be changed to match the originator product’s name after its initial biosimilar name has been determined. As a consequence of this proposal, interchangeable products may not likely be easily identifiable as interchangeable based on name alone.

Instead, Express Scripts asks FDA to abandon the use of a suffix altogether for naming biosimilars and suggests the use of standard nonproprietary names combined with active use of national drug codes (NDCs). The PBM claims that use of even two biosimilars (for filgrastim and infliximab alone) would produce savings of $22.7 billion during a period of 10 years after biosimilar approvals.

Importantly, Express Scripts’ letter also acknowledges the differences that can occur among batches of a biologic product, asking FDA if the agency’s approach to naming would require a reference biologic drug maker to “apply different suffixes to any product lines that vary from the composition of the drug filed with the NDA [new drug application] at the time of original application?”

Source: Regulations.gov