Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen's NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius Kabi's first biosimilar approved by the FDA on September 6, 2022 and is now Fresenius Kabi's first biosimilar to launch in the United States. STIMUFEND is approved for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
According to the press release, STIMUFEND "is commercially available in a 6 mg/0.6 mL solution in a single-dose pre-filled syringe combined with a passive needle guard."
As we previously reported, Fresenius Kabi received marketing authorization from the European Commission for STIMUFEND in March of 2022. Fresenius Kabi launched its pegfilgrastim biosimilar in October of 2022 in France.
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