On March 7, 2019 FDA updated the Center for Drug Evaluation and Research (CDER) Manual of Policies on Procedures (MAPP) for Nonproprietary Naming of Biological Products.  The material is referred to as MAPP 6720.5. 

This material describes procedures for handling requests for nonproprietary name suffix review for INDs and BLAs for originator biological products, related biological products, and biosimilar products to be used in the CDER.  Reference is made to the final FDA guidance issued in January of 2017 regarding nonproprietary naming of biological products, which notes that the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product is a proper name that is a combination of the core name and a distinguishing suffix that is: (1) designated by FDA, (2) devoid of meaning, and (3) composed of four lowercase letters. 

In particular, Division of Medication Error Prevention and Analysis (DMEPA) officials in the Office of Surveillance and Epidemiology (OSE) are authorized to take regulatory actions related to the approval of drugs for human use that are the subject of a BLA under CDER jurisdiction, including decisional letters regarding review of the nonproprietary name suffix candidate.  The policy and procedure material discusses the responsibilities of various offices within the CDER regarding review of nonproprietary name suffixes identified by FDA or proposed by a sponsor.  Some designated responsibilities are as follows:

  • DMEPA officials will add all the suffix candidates to FDA's internal database;
  • OSE Safety Regulatory Project Manager will serve as the point of contact for communications with the biological product sponsor or applicant regarding nonproprietary name suffixes;
  • DMEPA Biological Safety Evaluator will generate a four-letter suffix candidate upon request of the sponsor or applicant or DMEPA Director and initiate the assessment of the proposed suffix, taking into account criteria listed in the final guidance for industry;
  • DMEPA Director will sign the nonproprietary name suffix decisional letter to the application holder.

More information regarding nonproprietary naming of biological products can be found here. The material additionally may be applicable to interchangeable biological products as discussed in a recent FDA guidance update here.

Readers are encouraged to read MAPP 6720.5, also available on FDA's website.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.