Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement last week on the importance of naming biological medicines that will benefit by having a lower cost to patients.
The FDA says it believes biosimiliars will allow for greater access while still allowing for competition in the market. However, Gottlieb was against a specific naming pattern if it would cause harm to the public by allowing for the possibility that the biosimiliars would be thought of as an inferior product.
As a result, the FDA released an updated draft guidance on the same day as Gottlieb’s statement. The draft guidance highlighted three main points: no modification to the proper names of already licensed biological products; for interchangeable biosimiliars a proper name will include a suffix of four lowercase letters with no meaning; and the proper names of transition biological products will not have the naming convention. All products will also have nonproprietary names. The FDA believes this will help to track both originators and biosimiliars to promote patient safety by not letting patients think the biosimiliar medicine is inferior.
The original guidance from 2017 concerned stakeholders because of the vast amount of money it would cost to add suffixes to older biologics. Most likely that cost would have been passed down to individual patients who would already be confused by the change in the name of their medicine. The FDA realized the chances were too great that patient safety would be put at risk.
“After careful consideration, the FDA has determined that the crucial public health goals of the naming policy could still be accomplished by applying the naming convention to newly licensed biological products, while avoiding the negative consequences raised by extending the naming convention to previously licensed products,” Gottlieb said in the statement.
Currently, there are 17 approved biosimiliars with four-letter suffixes and the proper names of 27 originator biological products.
