Amgen’s ($AMGN) aging superstars have been under assault lately by Novartis’ ($NVS) Sandoz unit and its biosimilars ambitions. But the Big Biotech scored a break at the hands of regulators: The FDA rebuffed Sandoz's biosim version of Amgen's blockbuster Neulasta, Novartis disclosed Tuesday.
Within its Q2 results, Novartis revealed that its Neulasta biosimilar candidate had been turned down by the FDA, which issued a complete response letter after accepting the company’s application last November.
“We are working with the agency to address remaining questions,” the Swiss pharma giant said, without providing details.
It’s good news for Amgen, which has so far been the only victim of Sandoz’s biosimilar trailblazing in the U.S. Last year, Sandoz became the first to hit the U.S. market with a biosim--Zarxio, a copy of Amgen’s Neupogen--and it has also taken aim at the drugmaker’s anti-TNF giant Enbrel. An FDA advisory committee last week recommended that the agency green light Sandoz's copy in all of Enbrel’s approved indications.
Now, the California company has at least a bit more time to keep Neulasta’s blockbuster haul all to itself. Amgen’s No. 2 seller, behind Enbrel, Neulasta netted $4.72 billion in sales last year, with $3.89 billion of that coming in the U.S.
It’s not the first time the FDA has rejected an Amgen knockoff, either. Last October, regulators turned away Pfizer’s ($PFE) Hospira unit, which was seeking to pass muster with a biosimilar version of kidney disease drug Epogen.
And while the regulatory hurdles won’t keep biosimilars at bay forever, they’ll help keep Amgen’s top line stable while it pursues a biosimilar agenda of its own. It’s currently working to snag an OK for its copy of AbbVie’s ($ABBV) worldwide bestseller Humira, and last week that med scored backing from an FDA advisory panel.
- read the release
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