ENTtoday
  • Home
  • COVID-19
  • Practice Focus
    • Allergy
    • Facial Plastic/Reconstructive
    • Head and Neck
    • Laryngology
    • Otology/Neurotology
    • Pediatric
    • Rhinology
    • Sleep Medicine
  • Departments
    • Issue Archive
    • TRIO Best Practices
      • Allergy
      • Facial Plastic/Reconstructive
      • Head and Neck
      • Laryngology
      • Otology/Neurotology
      • Pediatric
      • Rhinology
      • Sleep Medicine
    • Career Development
    • Case of the Month
    • Everyday Ethics
    • Health Policy
    • Legal Matters
    • Letter From the Editor
    • Medical Education
    • Online Exclusives
    • Practice Management
    • Resident Focus
    • Rx: Wellness
    • Special Reports
    • Tech Talk
    • Viewpoint
    • What’s Your O.R. Playlist?
  • Literature Reviews
    • Allergy
    • Facial Plastic/Reconstructive
    • Head and Neck
    • Laryngology
    • Otology/Neurotology
    • Pediatric
    • Rhinology
    • Sleep Medicine
  • Events
    • Featured Events
    • TRIO Meetings
  • Contact Us
    • About Us
    • Editorial Board
    • Triological Society
    • Advertising Staff
    • Subscribe
  • Advertise
    • Place an Ad
    • Classifieds
    • Rate Card
  • Search

What Is a Biosimilar?

by Jennifer Fink • August 16, 2017

  • Tweet
  • Email
Print-Friendly Version

“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.”

You Might Also Like

  • Sinus Surgery Is Still an Essential Part of Patient Care
  • What Is a Biosimilar?
  • Why Otolaryngologists Should Embrace Off-Label Drugs, Devices
  • How the U.S. FDA Approves Medical Devices
Explore This Issue
August 2017

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.

Pages: 1 2 3 4 5 | Single Page

Filed Under: Features, Home Slider Tagged With: biologic drugs, biologics, biosimilar, otolaryngology, pharmaceuticalsIssue: August 2017

You Might Also Like:

  • Sinus Surgery Is Still an Essential Part of Patient Care
  • What Is a Biosimilar?
  • Why Otolaryngologists Should Embrace Off-Label Drugs, Devices
  • How the U.S. FDA Approves Medical Devices

The Triological SocietyENTtoday is a publication of The Triological Society.

The Laryngoscope
Ensure you have all the latest research at your fingertips; Subscribe to The Laryngoscope today!

Laryngoscope Investigative Otolaryngology
Open access journal in otolaryngology – head and neck surgery is currently accepting submissions.

Classifieds

View the classified ads »

TRIO Best Practices

View the TRIO Best Practices »

Top Articles for Residents

  • Do Training Programs Give Otolaryngology Residents the Necessary Tools to Do Productive Research?
  • Why More MDs, Medical Residents Are Choosing to Pursue Additional Academic Degrees
  • What Physicians Need to Know about Investing Before Hiring a Financial Advisor
  • Tips to Help You Regain Your Sense of Self
  • Should USMLE Step 1 Change from Numeric Score to Pass/Fail?
  • Popular this Week
  • Most Popular
  • Most Recent
    • The Dramatic Rise in Tongue Tie and Lip Tie Treatment
    • Vertigo in the Elderly: What Does It Mean?
    • Experts Delve into Treatment Options for Laryngopharyngeal Reflux
    • A Look at the Latest Research on Subglottic Stenosis
    • Weaning Patients Off of PPIs
    • Vertigo in the Elderly: What Does It Mean?
    • New Developments in the Management of Eustachian Tube Dysfunction
    • Some Laryngopharyngeal Reflux Resists PPI Treatment
    • Eustachian Tuboplasty: A Potential New Option for Chronic Tube Dysfunction and Patulous Disease
    • The Dramatic Rise in Tongue Tie and Lip Tie Treatment
    • Did You Receive COVID-19 Relief? Here Are Reporting Considerations for 2021
    • Otolaryngology Experts Share Best Practices in Five Areas
    • How Climate Change May Be Affecting Sleep Patterns for Adults and Children
    • Laryngologists Discuss Tough Tracheostomy Choices During COVID-19 Era
    • Head and Neck Cancer: Experts Discuss How to Improve Surgery Quality and Value

Polls

Did you receive funding from the CARES Act or Paycheck Protection Program?

View Results

Loading ... Loading ...
  • Polls Archive
  • Home
  • Contact Us
  • Advertise
  • Privacy Policy
  • Terms of Use

Visit: The Triological Society • The Laryngoscope • Laryngoscope Investigative Otolaryngology

Wiley
© 2021 The Triological Society. All Rights Reserved.
ISSN 1559-4939

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.