What Is a Biosimilar?

by Jennifer Fink •

“One of the things that could affect the market—and this happened in Europe—is that they didn’t do much switching in the beginning,” said Joseph Fuhr, PhD, adjunct professor of pharmaceutical and healthcare business at University of the Sciences in Philadelphia. “What happened was, if a doctor had a new patient, they would put them on the biosimilar but not switch anybody away from the original product.”

Dr. Fuhr expects what happened in Europe to happen in the U.S.: Uptake of biosimilars will improve, and costs will go down, when interchangeability is demonstrated.

“When small-molecule generics came out, there was a big outcry and a lot of skepticism,” said Hakim. “What is now an accepted fact in the U.S. medical system is that small-molecule generics are just as good; there’s no reason to be skeptical of them.

“I think the same thing is going to be true for biosimilars. Hopefully, as regulatory bodies and clinicians gain a level of comfort on the basis of rigorous scientific and clinical data, we’ll be able to use biosimilars with the same degree of comfort as we use small-molecule generics.”

Jennifer Fink is a freelance medical writer based in Wisconsin.

Take-Home Points

  • Biologics and biosimilars may soon become important therapeutic options in all areas of medicine, including otolaryngology.
  • Minor differences in manufacturing, processing, and packaging may result in meaningful differences in both biosimilars and the originator biologics.
  • Biologics are relatively new within the field of otolaryngology, and no biosimilars have been FDA approved for otolaryngologic indications.
  • Biosimilar use in otolaryngology likely will occur in the treatment of allergy, immunology, and chronic rhinosinusitis.

Hospitalists as Test Subjects

According to a 2014 study by the RAND Corporation, biosimilars will “lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024” (2017. Rand.org). In Europe, biosimilars typically cost at least 25% less than reference biologics. Will the United States see similar savings?

Maybe. “The federal approval of the first biosimilar in the U.S. was supposed to foster the development of new products that offered big discounts on some of healthcare’s most expensive treatments,” said Dr. Das. “But there’s been no flood of new drugs and no lower prices since the FDA’s approval of Zarxio.”

One key to potential savings will be the FDA requirements for interchangeability. If the FDA requires extensive, expensive clinical testing to prove interchangeability, cost savings may not be as significant as anticipated.