FDA Issues Draft Guidance for Naming Biologics and Biosimilars

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-31-2015 11:55


The US Food and Drug Administration (FDA) has issued draft guidance, Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability, which details the FDA’s proposal on the nonproprietary naming of biological products. In a joint FDA blog announcing the release of the draft guidance, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, highlighted the main issues proposed by the FDA in the draft guidance.

The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to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, FDA's roposal 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).

In their blog, Woodcock and Midthun said that the proposed naming convention seeks to address two main issues: (1) help prevent inadvertent substitution (which could lead to medication errors) of biological products that are not determined to be interchangeable by the FDA; and (2) 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.

FDA is also seeking public comment on what to consider to do to address previously approved biological products that have nonproprietary names without a suffix. FDA said that applying the naming convention to these products would encourage routine use of designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices and avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. Along those lines, the FDA is seeking comment on the best approach to implement this naming convention for previously licensed products. The 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.

Source: FDA Blog and FDA Draft Guidance


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