FDA shares plans on naming biological medicines to balance competition and patient safety
Since the biosimilar pathway was established in 2010, there’s been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance, said Food and Drug Administration Commissioner Scott Gottlieb, M.D.
“We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access,” Gottlieb stated. “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.”
In January 2017, the FDA published a guidance document in which the agency sought to balance these concerns by using a distinguishing suffix to the proper names of biological products, including not just biosimilars, but originator products as well. By applying this policy to originator and biosimilar products alike, the FDA sought to advance the goal of patient safety – which the suffixes promote – without creating a misimpression that products with such suffixes are somehow inferior to those without. In addition, FDA said it was considering the process to retrospectively change the names of biological products already on the market, to begin adding distinguishable suffixes.
FDA has announced an important update to the current policy with respect to the naming convention via an updated draft guidance. Those updates include the following:
- The FDA no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names.
- The FDA does not intend to apply the naming convention to the proper names of transition biological products.
- Going forward, for interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.
The agency says this framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market – originators and biosimilars – and promote patient safety. To aid in adverse event report tracking, originator, biosimilar and interchangeable products will have nonproprietary names that are distinct from each other. Additionally, any product that is first licensed as a biosimilar and later determined to be interchangeable will keep its nonproprietary name after receiving a determination of interchangeability.
