In response to the growing number of biosimilar approvals and increased acceptance of their safety and efficacy a number of global regulatory bodies have recently addressed or revisited the issue of naming biologic and biosimilar products.
At the crux of the debate is whether to include distinguishable suffixes in the naming of biological and biosimilar products. Other regulatory agencies, including the European Medicines Agency (EMA) of the European Union (EU) and Therapeutic Goods Administration (TGA) of Australia, have diverged from the U.S. Food and Drug Administration’s (FDA) position in regard to the naming of biologic and biosimilar products.
Generics, more affordable alternatives to their brand name counterparts that have identical active ingredients, are identified by their International Non-Proprietary Name (INN) (a unique name designated by the World Health Organization (WHO) that identifies the active ingredient in a drug) and share the same INN as the brand product. Because biosimilars are highly similar versions of their brand reference product, and not identical, proponents argue for the necessity of a suffix in addition to the INN for purposes of pharmacovigilance and avoiding patient and prescriber confusion.
However, the Council and numerous other stakeholders, including pharmacists, health plans, pharmacy benefit managers and consumer groups, attest that the addition of a suffix could have the opposite effect and lead to patient and prescriber confusion, increase the possibility of medication errors and effectively separate the biosimilar from existing safety information about the underlying molecule.
All FDA-approved biosimilars are approved for treatment of each of the therapeutic indications that their reference products are indicated to treat. Adding a suffix to biosimilar products that are approved to treat the same diseases as their reference biologics would serve only to confuse patients and prescribers while simultaneously undermining confidence in the safety and efficacy of these products.
Despite significant pushback, FDA finalized its guidance regarding the naming of biologic and biosimilar products in January 2017. FDA states that “each…biosimilar product will be 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.” FDA goes on to state that “…this naming convention will facilitate pharmacovigilance for…[and] will also facilitate accurate identification of these biological products by health care practitioners and patients.”
The use of a distinguishable suffix in the United States is at odds with the EU, which does not require a suffix, instead using identification tools that already exist within its pharmacovigilance system including INN, brand name and batch number. The EU has approved the greatest number of biosimilar medicines worldwide and has acquired considerable experience around their use and safety. “Over the last 10 years, the EU monitoring system for safety concerns has not identified any difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicine.”Further, the preliminary results of an ongoing EMA pharmacovigilance study showed that 95.5 percent overall product identification has been achieved for classes of biologicals for which biosimilar medicines have been approved.
In other words, the absence of a suffix for biosimilar products has not resulted in an increase in adverse events due to prescriber confusion or the misidentification of products that are involved in such an event.
In light of the EU’s experience and global stakeholder concerns the WHO suspended its proposal to add a suffix to its biologic and biosimilar naming convention, known as a Biological Qualifier or BQ. The Therapeutic Goods Administration (TGA) of Australia also opted not to include a suffix in its naming convention when it recently revisited the issue.
It is the Biosimilars Council’s position that pharmacovigilance and safety concerns have long been addressed by current naming conventions. These eliminate the need for unnecessarily complicated and confusing suffixes. There is no compelling reason to add additional identifiers for biosimilar drugs. Moving forward, we hope FDA reconsiders its position on this issue and other global regulatory agencies use the plethora of safety evidence established worldwide not to move forward with naming proposals for biosimilar products that confuse patients and prescribers and undermine confidence in these more-affordable alternatives to costly biologic medicines.