By: Janet Woodcock, M.D. and Karen Midthun, M.D.
To create market competition among biological products and lower costs, the Affordable Care Act created a new approval pathway for products that are biosimilar to and interchangeable with FDA-licensed biological products. The FDA is committed to encouraging the development of these biosimilar and interchangeable products. Biological products derived from living organisms can treat patients with cancer, chronic kidney diseases and auto‐immune diseases, such as rheumatoid arthritis and inflammatory bowel disease.
Earlier this year, the agency approved the first biosimilar, and other products are in development. But one key issue is how to name biological products to ensure safe use and foster acceptance of these new products.
So today we are releasing a draft guidance that details the FDA’s proposal on the nonproprietary naming of biological products.
Our draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to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. 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, our 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 (e.g., the nonproprietary name of both the reference product and the interchangeable product could be replicamab-cznm).
The proposed naming convention seeks to address two main issues:
- 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.
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.
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. 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, FDA is seeking comment on the best approach to implement this naming convention for previously licensed products. 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.
We encourage the public to provide input on the FDA draft guidance and proposed rule by making comments to the appropriate dockets. We will consider all comments as we finalize the guidance and the rule. We also invite the public to respond to the questions posed by FDA in the notice announcing the availability of the draft guidance and will consider these responses in finalizing the guidance and the rule.
For more information: www.fda.gov/biosimilars
Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research
Karen Midthun, M.D., is the Director of FDA’s Center for Biologics Evaluation and Research