by Amanda Conschafter, Blog Editor
What’s in a name? A lot, as the Food and Drug Administration and World Health Organization are discovering. The two regulatory bodies are considering naming guidelines for biosimilar medications. The issue, also the topic of a newly released Institute for Patient Access policy brief, once again poises questions how to balance access and potential cost savings while ensuring patient safety.
Prescription medications typically carry two names: the brand name, selected by the manufacturer, and the non-proprietary (or “established”) name, determined by the United State Adopted Names Council. Doctors and health care professionals generally refer to medications by their non-proprietary names. With traditional, synthetic medications, both the original drug and the generic “follow on” medications carry the same non-proprietary name. For example, the popular anti-depressant Prozac is known by the non-proprietary name fluoxetine, which its generic equivalents also use.
The proponents of unique names, argue that these same naming rules should not apply to biological medications. Because biological medications are generated from human cells, they do not lend themselves to exact duplication. Thus, biologics can resemble one another but cannot be identical, as can name-brand synthetic drugs and their generic equivalents. Naming conventions that disregard differences among biological medications, patient advocates say, present opportunities for confusion about the source of side effects and changes in patient response.
Opponents to requiring distinct names – including generic drug manufacturers and several U.S. lawmakers – argue that different names complicate physicians’ jobs, and also might undermine expected cost savings.
The authors of the new IfPA policy brief maintain that unique names promote patient well-being. Being able to quickly, accurately determine which biological medication a patient takes allows doctors to identify and address problems, keeping patients safe. It also equips physicians to determine which medication works best for their patients. And for cancer, multiple sclerosis and rheumatoid arthritis patients – among those typically treated by biological medications – it minimizes time spent unnecessarily in pain.