BREAKING NEWS: U.S. FDA Approves First Pegfilgrastim Biosimilar (UPDATED)

 

Today, the U.S. FDA announced that it has approved Mylan’s aBLA for Fulphila™ (pegfilgrastim-jmdb), a biosimilar of Amgen’s Neulasta®.  This approval marks the eleventh FDA licensure of a biosimilar product under the BPCIA regulatory scheme, following last month’s approval of Pfizer’s Retacrit™ (epoetin alfa-epbx), and the first time the FDA has approved a pegfilgrastim biosimilar.  In a joint statement, Mylan and its collaboration partner Biocon noted that Fulphila™ is “the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S.”  According to the press release, “Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients.”

Several other biopharmaceutical companies are developing biosimilars of Neulasta®, including, among others, Sandoz, Apotex, and Coherus, who have each submitted an aBLA but have yet to gain approval.

Mylan is presently engaged in BPCIA litigation regarding its pegfilgrastim biosimilar application in the U.S. District Court for the District of Western Pennsylvania.  Most recently in that action, which is in the fact discovery phase, Mylan moved for judgment on the pleadings on one of the patents-in-suit, a motion which Amgen opposesSandoz, Apotex and Coherus have also engaged in BPCIA litigations against Amgen regarding their respective proposed pegfilgrastim biosimilars, with Apotex having obtained a Federal Circuit affirmance of its district court victory late last year, and Amgen’s appeals of district court judgments in favor of Sandoz and Coherus pending before the Federal Circuit.

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