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FDA issues guidance on naming biological products

The move is aimed at helping to prevent inadvertent substitution, and support safety monitoring of all biological products.

The FDA has released a draft guidance that details the agency's proposal on the nonproprietary naming of biological products, according to a recent blog post on FDA Voice.

The draft guidance proposes that "reference products and biosimilars have nonproprietary names that share a core drug substance name and, in order to better identify each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 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."

The new proposals are meant to address two major issues, according to the post, written by Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, M.D., Director of FDA’s Center for Biologics Evaluation and Research:

"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."

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