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First Biosimilar Receives Legal Clearance for US Market
Zarxio (filgrastim-sndz), manufactured by Sandoz as a biosimilar to Amgen's Neupogen, has finally received marketing approval from a federal appeals court.
Sandoz has finally received permission to commercialize its biosimilar filgrastim-sndz (Zarxio), 6 months following regulatory approval. While rejecting Amgen's claims of unfair competition, a federal appeals court has mandated that Novartis wait till September to bring the product to market. The court ruling handed down Tuesday states that companies marketing new biosimilars must give 180 days advance notice to the original drugmaker, in this case Amgen, after receiving FDA approval. This gives the original manufacturer of the biological 6 additional months of exclusive marketing rights.
The progress in this case has been closely watched by payers, patients, and drug manufacturers because biosimilars are forecast to save an estimated $44 billion in US healthcare costs over the next decade.
Read more in The Wall Street Journal.
"The Barriers Are Real": Antoine Keller, MD, on Geography and Cardiovascular Health
April 18th 2025Health care disparities are often driven by where patients live, explained Antoine Keller, MD, as he discussed the complex, systematic hurdles that influence the health of rural communities.
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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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Racial Differences in CA-125 Levels Tied to Ovarian Cancer Treatment Delays
April 17th 2025Black and American Indian women with ovarian cancer were less likely to have elevated cancer antigen 125 (CA-125) levels at diagnosis, resulting in delayed chemotherapy initiation and highlighting the need for more inclusive guidelines.
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