In an effort to ensure safe use and foster the acceptance of recently approved biosimilar products, the U.S. Food and Drug Administration (FDA) has released a draft guidance that details its proposal on the nonproprietary naming of biological products.
The FDA suggests that reference products and biosimilars have nonproprietary (proper) names that share a core drug substance name. To better identify each product, names will also include an FDA-designated suffix unique to each product, composed of four lowercase letters. 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 FDA is requesting feedback from the public about whether the nonproprietary name for such a product should include a distinct suffix or share the same suffix as its reference product.
The proposed naming convention seeks to support safety monitoring of biological products after they are on the market as well as prevent inadvertent substitutions of biologics that aren’t interchangeable. The FDA is also seeking comment on the best approach to implement this naming convention for previously licensed products.
In addition to the draft guidance, the FDA is issuing a proposed rule to designate nonproprietary names that contain a suffix for six previously licensed biological products.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.
The FDA encourages the public to provide input on the draft guidance and proposed rule and will consider all comments before finalizing them.
For more information, visit www.fda.gov/biosimilars.