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The Top 5 Biosimilar Articles for the Week of August 23 – The Center for Biosimilars

Aug 28th, 2021

Hi, Im 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.

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The Top 5 Biosimilar Articles for the Week of August 23 - The Center for Biosimilars

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