The US Food and Drug Administration (FDA) has released an updated draft guidance that will update the naming convention of biological medications. The updated policy will provide consistency among products and ensure that healthcare providers and patients have confidence in the safety and effectiveness of products on the market.
There has been ongoing debate about the naming convention of biologics since the biosimilar pathway was established in 2010. Some have argued that a unique identifier should be added to the proper names of biologic products to ensure strong pharmacovigilance, while others note that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition.
“We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access,” said FDA Commissioner Scott Gottlieb, MD, in his statement. “And we’re fully committed to the suite of announced and upcoming policies to help advance the goal of a robust, high-quality, competitive market for biosimilar products. But I do not believe that the naming convention should be used to advance these goals if it could come at the expense of the ability to ensure patient safety. Nor do I believe the inclusion of a suffix will frustrate the broader aim of inspiring strong biosimilar competition.”
The FDA published a guidance document in January 2017 that announced the use a distinguishing suffix for the proper names of biologic products, including both biosimilar and original products.
In the updated draft guidance, the FDA has outlined the following changes:
- The agency will no longer modify the proper names of biologic products that have been approved under the Public Health Service Act without an FDA-designated suffix in their proper names.
- The naming convention will not be applied to the proper names of transition biologic products.
- For interchangeable biosimilars, the agency will designate a proper name that combines the core name and a distinguishing suffix that is devoid of meaning and composed of 4 lowercase letters.
“As we move closer to the 2020 transition, we know that the FDA’s biologics naming policy is a component of broader efforts to help facilitate robust competition among biologics,” Dr Gottlieb stated. “Our primary goal with respect to the naming convention is to matters of patient safety. But, we’re cognizant of – and responsive to – how these decisions impact competition and we shaped our policy with these considerations also in mind.”
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products [news release]. Silver Spring, Maryland: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632870.htm. Published March 7, 2019. Accessed March 7, 2019.