U.S. FDA
FDA officials recently announced the availability of draft guidance on the nonproprietary naming of biological products, calling it a key issue for ensuring their safety and promoting their acceptance.
An FDA blog post by Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, describe the guidance.
“Our draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to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,” they wrote. “This suffix would be composed of four lowercase letters, and not carry any meaning.”
According to the draft guidance, this naming convention applies to biological products previously and newly licensed under the Public Health Service Act, and aims to clearly differentiate biological products the FDA has not determined to be interchangeable. This will help prevent inadvertent substitution of such biological products, and make it easier to track use of biological products in all health care settings to improve safety monitoring, according to the blog post.
Nonproprietary names for originator and related biological products and biosimilars will include unique suffixes, but the proposal requests public feedback regarding whether the nonproprietary name for an interchangeable biological product should share its reference product’s suffix or have its own distinct suffix. Public feedback has also been requested on the pros and cons of other naming conventions, and implementation of the naming convention for previously licensed products.
The FDA has also issued a proposed rule to assign nonproprietary names with a suffix to six previously licensed biological products, including filgrastim-sndz (Zarxio, Sandoz), filgrastim (Neupogen, Amgen), tbo-filgrastim (Granix, Teva Pharmaceuticals), pegfilgrastim (Neulasta, Amgen), epoetin alfa, and infliximab (Remicade, Janssen). Each of these are “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,” according to the blog post.
“Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway,” according to the draft guidance.
The FDA will consider comments on the draft guidance for 60 days and on the proposed rule for 75 days after August 28, the date of publication in the federal register, according to its website.