Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky

Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.

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Mylan NV is set to launch Fulphila (pegfilgrastim-jmbd), the first biosimilar to Amgen Inc.'s Neulasta approved by the US FDA, "in the coming weeks" despite ongoing patent litigation with Amgen.

FDA approved the biosimilar on June 4 after Mylan and its partner Biocon Ltd. overcame regulatory hurdles that have...

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