Novartis silently yanks a troubled biosimilar application; Chinese antibody developer draws $39M round
• Novartis never has tried to explain why the FDA has rejected its biosimilar of Amgen’s Neulasta. And it’s being equally reticent about its decision to yank its application in Europe. The “application for a marketing authorization for Zioxtenzo (pegfilgrastim) has been withdrawn,” the EMA noted today. “Zioxtenzo was developed as a biosimilar medicine to treat neutropenia in cancer patients.” Novartis loves to highlight its R&D progress, but setbacks are dealt with silently. The EMA, though, did explain that the biosimilar appeared to be unapprovable. “One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta. The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site. An inspection of the site will therefore be needed before the medicine can be approved.”
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