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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.
Stuck in Prior Auth Purgatory: The Hidden Costs of Health Care Delays
June 19th 2025Delays, denials, and endless paperwork—prior authorization isn’t just a headache for providers; it’s a barrier for patients who need timely care, explains Colin Banas, MD, MHA, chief medical officer with DrFirst.
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In R/R Marginal Zone Lymphoma, 90% Alive at 2 Years After Liso-Cel
June 24th 2025In a cohort of TRANSCEND FL, the chimeric antigen receptor T-cell therapy liso-cel showed a 95% overall response rate in relapsed marginal zone lymphoma, offering hope for improved patient outcomes in challenging cases.
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