The BPCIA and the Debate Over Naming Biosimilars
Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible, however, to create an exact duplication of large-molecule biologic products. Thus, manufacturers that seek to replicate branded biologics use slightly variant living organisms or processes to create products referred to as “biosimilars.” The 2010 Biologics Price Competition and Innovation Act (BPCIA) established an abbreviated pathway for FDA approval of biosimilars. To receive FDA approval for a biosimilar drug, a manufacturer must demonstrate that the biosimilar is “highly similar” to a reference biologic, and that there are “no clinically meaningful differences” in safety, purity and potency between the biosimilar and the reference product. 42 U.S.C. § 262(i)(2). Manufacturers can also seek FDA approval for a biosimilar to be approved as “interchangeable” with a reference drug, meaning that, if approved, the biosimilar can be substituted for a reference drug without the intervention of a prescribing doctor.
The BPCIA, however, did not provide guidance on how biosimilars should be named. Some manufacturers opined that unique non-proprietary names for biosimilars were essential to ensuring patient safety and optimizing pharmacovigilance. Because spontaneous reports of adverse events from patients and health care providers generally do not include specific product identification information, these manufacturers argued that giving biosimilars a unique product name would increase the odds that an initial report would correctly identify the product at issue, and aid in responding quickly to potential safety concerns. Others, however, believed that the continued use of national drug codes and lot numbers would suffice to support pharmacovigilance efforts with biosimilar products, and offered that unique non-proprietary names could actually undermine the FDA’s review process and lead to confusion in the marketplace that might limit patients’ access to biosimilars. They argued further that tracking adverse events would not be helped by using non-proprietary names for biosimilars, given that such names are not used in national and regional pharmacovigilance systems to facilitate the detection of new safety information related to pharmaceutical substances on a global level.
The FDA’s Final Guidance on Naming Biologics, Including Biosimilars
On January 12, 2017, the FDA released Nonproprietary Naming of Biological Products: Guidance for Industry, providing the FDA’s final guidance as to how biologics, not just biosimilars, should be named (Final Guidance). The Final Guidance outlines as follows:
- The nonproprietary name of “each originator biological product, related biological product, and biosimilar product” will be a combination of the product’s general (core) name and a four-letter suffix that is devoid of meaning.
- The FDA exemplified this by explaining that names for products sharing the core name “replicamab” could be “replicamab-cznm,” or “replicamab-hjxf.”
- The FDA intends to require a similar naming convention for interchangeable drugs, but it is still in the process of considering the appropriate suffix format for those drugs.
- Biologic drug manufacturers are now required to propose suffixes comprised of four lowercase letters to the FDA. Specifically, manufacturers should submit up to 10 proposed suffixes, in order of preference, that are:
- devoid of meaning
- four lowercase letters, at least three of which are distinct
- attached to the core name of the drug with a hyphen
- free of legal barriers that would restrict use of the suffix
- Previously licensed biologics with names that do not meet the requirements of the Final Guidance will need to undergo name changes. The FDA is still considering the process for implementing the name changes, but in the near term, the FDA intends to assign distinguishing suffixes to a limited group of these products. The FDA will also accept submissions of prior approval supplements from drug manufacturers that wish to propose suffixes for their biologic products.
- In the past, the FDA attached a prefix to certain biologic drug names in an effort to distinguish those drugs from previously licensed products and promote pharmacovigilance, and the FDA may continue this practice in limited circumstances where appropriate.
Rationale Behind the Guidance
The FDA explained that it believed a unique suffix should be assigned to biologics in an effort to enable both health care practitioners and patients to identify different biologic products without confusion, and to prevent the inadvertent substitution of biological products that have not been deemed interchangeable. According to the FDA, its chosen naming convention will also help manufacturers identify the correct product at issue with ease in response to claims made by consumers, and if necessary, assist manufacturers in determining which products require remedial action. In addition, the FDA has pointed out that the naming convention will ensure accurate product identification in billing and claims records used for pharmacovigilance purposes, as other product-specific identifiers such as national drug codes or proprietary names are not always available and may change during the life of a product. It is yet to be seen, however, how quickly the Final Guidance’s naming convention will be implemented, and whether its intended effects will be realized.