• Bone Health
  • Immunology
  • Hematology
  • Respiratory
  • Dermatology
  • Diabetes
  • Gastroenterology
  • Neurology
  • Oncology
  • Ophthalmology
  • Rare Disease
  • Rheumatology

The Top 5 Biosimilar Articles for the Week of August 23

Video

Here are the top 5 biosimilar articles for the week of August 23, 2021.

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of August 23, 2021.

Number 5: UnitedHealthcare (UHC) has changed its policy to indicate that the bevacizumab biosimilars Mvasi and Zirabev will not be covered in the treatment of certain ophthalmic conditions or considered ophthalmically equivalent to Avastin, the reference product.

Number 4: Rumors that HHS could calculate payment for biosimilars differently under a potential policy change have sparked concerns among providers and biosimilar developers. If the rumors are correct, the Medicare Part B payment methodology for biosimilars would be overhauled for the second time in 4 years.

Number 3: How many switches between a biosimilar and reference product will be sufficient to demonstrate that the risk of transitioning is minimal? A virtual study verified the strength of FDA guidance.

Number 2: A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.

Number 1: Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggested that using the 351(a) pathway for standalone drugs and copy products may be faster and better in part 3 of a series.

To read all of these articles and more, visit centerforbiosimilars.com.

Recent Videos
Here are the top 5 biosimilar articles for the week of February 10, 2025.
Here are the top 5 biosimilar articles for the week of February 3, 2025.
Josh Canavan, PharmD, head of pharmacy at RazorMetrics
Here are the top 5 biosimilar articles for the week of January 27, 2025.
Here are the top 5 biosimilar articles for the week of January 20, 2025.
Here are the top 5 biosimilar articles for the week of January 13, 2025.
Sarah Hudson-DiSalle, PharmD, RPh, FACCC
Tiago Biachi, MD, PhD
Here are the top 5 biosimilar articles for the week of December 30, 2024.
Related Content
© 2025 MJH Life Sciences

All rights reserved.