FDA unveils draft guidance for naming biosimilars

SILVER SPRING, Md. — The Food and Drug Administration late last week released its draft guidance on the naming of biological drugs. The guidance was outlined in a blog post by Janet Woodcock, director of the FDA’s center for drug evaluation and research, and Karen Midthum, director of the FDA’s center for biologics evaluation and research.

The draft proposes that a reference products and biosimilar drugs’ proper name also carry a four-character suffix composed of lower-case letters that don’t carry any meaning. The example given by FDA is that a reference product would be called “replicamab-cznm” and the biosimilar version could be called “replicamad-hixf.”

The guidelines are aimed at preventing inadvertent substitution of biosimilars that the FDA doesn’t deem to be interchangeable and to ensure that those on the market can be easily and accurately tracked from hospital to pharmacy, according Woodcock and Midthum.

“In addition to thinking ahead, we must also consider what we need to do to address previously approved biological products that have nonproprietary names without a suffix,” they wrote. “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.”

In the blog post, Woodcock and Midthum also noted that the FDA is issueing a proposed rule to create suffixes for six already licensed biological products. The FDA is currently accepting input from the public on the draft guidance and proposed rule.