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The Biosimilar War Is Not Over Yet
Will Sandoz' biosimilar, first ever in the US, ever see the light of day?
While Sandoz was granted regulatory approval for it's Zarxio biosimliar, filgrastim-sndz, back in March, the product has not yet reached the market...and may not for a while if Amgen has it's way.
Amgen's Neupogen, approved by FDA in 1991, is a therapy to help increase cancer patients’ white blood cell counts and fight infections. The drug, which costs approximately $3000 for each chemotherapy cycle, generated $839 million in US sales last year for Amgen. Amgen is fighting to prevent Novartis AG, the parent company of Sandoz, from marketing the product, citing copyright issues with biologic manufacturing.
Arguments from both sides were heard in a Washington appeals court yesterday.
Read more on Bloomberg: http://bloom.bg/1Qabmy0
FDA Approves Pegcetacoplan for Rare Kidney Diseases C3G, Primary IC-MPGN in Patients 12 and Older
July 29th 2025The FDA approved pegcetacoplan (Empaveli; Apellis Pharmaceuticals) as the first treatment for patients 12 years and older with the rare, severe kidney diseases C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
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