FDA Approves Amneal’s Biosimilar of Neulasta
This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.
The FDA has approved Amneal Pharmaceuticals’ biologics license application for Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Amgen’s Neulasta (pegfilgratim). Fylnetra was developed in collaboration with Kashiv Biosciences. It is used to decrease the risk of infection after chemotherapy.
Four other biosimilars have been approved by the FDA: Fulphila, co-developed by Biocon Biologics and Mylan; Nyvepria, developed by Pfizer; Udenyca, developed by Coherus BioSciences; and Ziextenzo, developed by Sandoz, a division of Novartis.
This marks the third biosimilar approval Amneal received this year for products used in oncology. Earlier this year, the FDA approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen, and Alymsys (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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