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.
Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Remicade in IBD
February 15th 2025Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
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