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Recent Articles

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Amgen and Kashiv Biosciences get US approval for Fylnetra, a biosimilar to Amgen’s injectable Neulasta pegfilgrastim to treat neutropenia resulting from chemotherapy; in 12 months ending March 2022, Neulasta biosimilars had US sales of US$1B

FDA approves Amneal’s BLA for injectable Alymsys bevacizumab-maly Avastin biosimilar to treat cancer; oncology is second largest biosimilar category in US, with IQVIA reporting 2021 bevacizumab sales at US$2.6B, of which US$1.6B were biosimilars

Amneal receives sub-license from Medicines Patent Pool to make generic oral nirmatrelvir co-packaged with oral ritonavir to treat mild, moderate COVID-19 in 95 low-, middle-income countries; Amneal to make nirmatrelvir in India, ritonavir in US, India

Amneal receives FDA approval for filgrastim-ayow biosimilar to treat neutropenia, with product launch planned for Q3 this year; IQVIA reports 2021 US biosimilar sales of US$275M, with Amneal launching two more biosimilars later this year

Amneal introduces generic dexamethasone, azacitidine, carboprost, atropine injectables for institutional market; company plans over 40 new products by 2025 including drug/device combinations, peptides, long-acting injectables, large-volume parenteral bags

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