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Biosimilars Await Naming Guidance From FDA
Sandoz's biosimilar will be sold under the trade name Zarxio but the FDA has held off on releasing a naming policy for biosimilars, giving the product a "placeholder nonproprietary name" of "filgrastim-sndz."
Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a biosimilar of Amgen’s Neupogen (filgrastim) product. The FDA has, however, held off on releasing a naming policy for biosimilars, giving the product a “placeholder nonproprietary name” of “filgrastim-sndz.”
The FDA has stated that this placeholder name “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products” and that the agency intends to issue naming guidance in the “near future.”
Read more at Biologics Blog: http://bit.ly/1FycpNd
Varied Access: The Pharmacogenetic Testing Coverage Divide
February 18th 2025On this episode of Managed Care Cast, we speak with the author of a study published in the February 2025 issue of The American Journal of Managed Care® to uncover significant differences in coverage decisions for pharmacogenetic tests across major US health insurers.
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Impact of Hospital-Physician Integration on Medicare Patient Mix
April 11th 2025This study found no evidence that hospital employment of physicians resulted in physicians treating sicker patients, undercutting claims that hospital-employed physicians serve a higher-acuity patient mix.
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