Peter J Pitts
Center for Medicine in the Public Interest, USA
Title: The urgency of biosimilar nomenclature
Biography
Biography: Peter J Pitts
Abstract
Biologic drugs are extremely complex medicines. As such, unlike traditional chemical drugs, it is all but impossible for biosimilar drugs to be identical to the approved biologic they are meant to resemble. The naming of these drugs is an important patient safety issue because the INN is used in the surveillance of drugs on the market to quickly identify which drug may be responsible for an adverse event. If biosimilars use the same INN as their reference biologics, it would be more difficult for regulators to recognize exactly which product is causing a problem. As the Food and Drug Administration (FDA) finalizes its naming policy, the agency must learn from real-world global biosimilar experiences to understand how different a biosimilar can be from the original biologic. These differences will make it resoundingly clear that FDA must finalize its policy in favor of unique names. Case in point: A poster presentation at the European Crohn’s and Colitis Organization titled “Biosimilar but not the same” offered timely and real-world data on the differences between originator biologics and their biosimilars. The study examined the clinical impact of both the innovator product (Remicade) and its European Medicines Agency-approved biosimilar (Inflectra). The findings show the rates of surgery in Remicade and Inflectra groups were significantly different. Specifically, 80 percent of the Inflectra group required hospital readmission versus 5 percent of the Remicade group. The conclusion of the study is not ambiguous: “Our results suggest that biosimilars may not be as efficacious as the reference medicine.” Biosimilar approvals are based on similarity — but in the real world, success will be measured by patient outcomes. Biosimilars are here to stay and it is not surprising that physicians will have more confidence in them if they know exactly what drug they are prescribing. Distinguishable names provide that transparency and a necessary safeguard to maximize safety and credibility. It’s really that simple.