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Big Molecule Watch
May 22, 2023

Amneal Launches FYLNETRA (pegfilgrastim-pbbk) in the United States

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States.  According to the press release, FYLNETRA—Amneal’s third biosimilar launch in the United States since late last year—is used to treat neutropenia (low neutrophils, a type of white blood cell that fights infection) which is commonly experienced by patients undergoing chemotherapy.  Amneal developed FYLNETRA in collaboration with Kashiv Biosciences, a biopharmaceutical company located in Chicago, Illinois.

Amneal’s FYLNETRA is the sixth pegfilgrastim biosimilar to be launched in the United States, behind Mylan’s FULPHILA (launched in July 2018); Coherus’s UDENYCA (launched in January 2019); Sandoz’s ZIEXTENZO (launched in November 2019); Pfizer’s NYVEPRIA (launched late 2020 or early 2021); and Fresenius Kabi’s STIMUFEND (launched in February 2023).

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