FDA Updates Biological Product Naming Guidance
FDA has issued an updated draft guidance, Nonproprietary Naming of Biological Products, indicating that the agency no longer intends to modify the proper names of biological products that have already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 document also says that FDA does not intend to apply the naming convention to the proper names of transition products and, in the future, intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning, composed of four lowercase letters.
In a statement, FDA commissioner Scott Gottlieb says the revised framework “will help secure pharmacovigilance so that 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, under this updated policy, 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.”
Gottlieb says that after issuing its 2017 naming guidance, the agency heard stakeholder concerns that changing the names of older biologics by adding suffixes would impose substantial costs on the healthcare system and potentially could create confusion that could increase risks to patients as drug names don’t often change once a drug is on the market. “After careful consideration,” he writes, “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.”
The statement says the naming policy is being developed with a view to the 3/2020 transition when the biosimilar and interchangeable pathway will open to additional products such as insulin.
As part of the update, FDA says it is continuing to carefully consider the application of the naming convention to vaccines. “In view of the existing framework for ensuring safety reporting and monitoring for vaccines, the agency is carefully considering whether the information that’s already available to us through identification systems associated with the administration of vaccines is sufficiently robust for ensuring pharmacovigilance such that we may not need distinguishable proper names with suffixes for vaccines.”