Opinion: U.S. biologics and biosimilars need distinguishable names

With seven biosimilars currently on the market and 18 biosimilars approved by the FDA as of April 2019, one question is sparking a lot of debate: What should the scientific, or nonproprietary, names of these products be?

There are two schools of thought on this. One says that a molecule that is highly similar to its reference biologic medicine should have the same nonproprietary name as the originator. The other says that for safety reasons it’s important to have distinct names for all biologics so we can more easily tell one from another. The naming decision extends far beyond marketing and directly affects how pharmacies fulfill prescriptions for these drugs and how they will be monitored once they’re on the market.

All biologics — biosimilars included — are complex medicines with complex manufacturing processes and distinct from small molecule therapies. In that world, generic drugs share the same nonproprietary names as their brand-name reference drugs because they share identical active ingredients. For example, all generic versions of Tylenol (acetaminophen) are .