By Robert Yapundich, M.D.
Biologics are the fastest growing segment of new medical breakthroughs. The hope is for biosimilars to be brought to market through a newly developed pathway for U.S. approval, ultimately bringing down the costs associated with these blockbuster therapies. Through this process, I have kept close tabs on the advancement and promise of biosimilars entry into the U.S. market. As a practicing neurologist I prescribe biologic drugs on a daily basis to treat complex disorders such as multiple sclerosis (MS), migraines and cervical dystonia. I look forward to expanding treatment options to my patients, but only with the assurance of safety.
Before biosimilars come to market, the U.S. Food and Drug Administration (FDA) must finalize several relevant policies, including whether these therapies should have the same or distinguishable names. While the naming of biologics may not seem relevant outside of policy circles, it has the potential to dramatically affect patients by impacting our ability to track adverse drug events (ADE). According to the Centers for Disease Control and Prevention (CDC), ADE’s already cost $3.5 billion in extra medical costs annually; what’s even worse, the Institute of Medicine (IOM) has concluded that preventable medical errors are the sixth leading cause of death in America and according to the FDA, over 1.3 million people are injured each year due to medication mistakes.
Individually distinguishable names for all biologics, including biosimilars, will create greater clarity, while promoting better safety monitoring, ADE reporting, and timeliness in managing any ADEs. The ability to distinguish between products will help doctors better understand any differences in efficacy among patient populations (e.g., minorities, elderly, children, etc.) and potentially advance the development of even more effective products in the future.
Despite such obvious advantages with a distinguishable naming system, the Federal Trade Commission (FTC) seems to believe that non- distinguishable names will create a more competitive environment between innovators and biosimilars. Unfortunately, such an approach could backfire if problems arise with one biosimilar, creating a situation that prevents the medical community from quickly distinguishing the flawed product, and ultimately taints trust toward all biosimilars.
As a neurologist, I realize the importance of knowing which medications are being taken by my patients, and the need to quickly isolate the source of any ADE. The ability to accurately track medications enables me to effectively pursue a corrective course of action in the event of any ADE.
It is my hope that FTC moves from its current course and adopts a position that benefits patients now and into the future. Only through a fair and comprehensive process that includes perspectives from all pertinent parties will regulators be able to ultimately balance competition among biosimilar agents with policy that promotes patient safety, clarity and scientific transparency. The Year of the Biosimilars has arrived. Let’s take our best step forward.
Dr. Robert Yapundich is a neurologist practicing in Hickory, NC and a member of the Alliance for Patient Access.