FDA Draft Guidance Issued for Naming and Biological Products
Thursday, August 27, 2015
In a recent FDA blog post, details were shared regarding the release of a draft guidance that details the FDA’s proposal on the non-proprietary naming of biological products.
The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters, and not carry any meaning. For example, the nonproprietary name of a reference product could be replicamab-cznm, and a biosimilar to that product could be replicamab-hixf.
For interchangeable biological products, the proposal requests feedback from the public about whether the nonproprietary name for such a product should include a distinct suffix, or should share the same suffix as its reference product (e.g., the nonproprietary name of both the reference product and the interchangeable product could be replicamab-cznm).
The proposed naming convention seeks to address two main issues:
- To help prevent inadvertent substitution (which could lead to medication errors) of biological products that are not determined to be interchangeable by the FDA; and,
- To support safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage of biological products in all settings of care, such as outpatient, hospital, and pharmacy settings.
FDA is also considering, and has requested public input on, the benefits and challenges of other naming approaches, such as a suffix derived from the name of the license holder.
Consideration must also be given to address previously approved biological products that have nonproprietary names without a suffix. Applying the naming convention to these products would encourage routine use of designated suffixes in ordering, prescribing, dispensing, and record keeping practices and avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.
Along those lines, FDA is seeking comment on the best approach to implement this naming convention for previously licensed products.
FDA also is issuing a proposed rule to designate nonproprietary names that contain a suffix for six previously licensed biological products. Each of the six products is either a reference product for an approved or publicly disclosed biosimilar product application or a biological product that is either biosimilar to or related to one of these reference products.
FDA encourages the public to provide input on the FDA draft guidance and proposed rule by making comments to the appropriate dockets. All comments will be considered as the guidance and the rule are finalized. Responses are also requested for the questions posed by FDA in the notice announcing the availability of the draft guidance.