Another Biosimilar Granted FDA Approval, Thanks To Novartis
Another day, another unanimous FDA panel vote, this time recommending Novartis’ ($NVS) Enbrel (etanercept) biosimilar be approved across all of its U.S. licenses. Recently the FDA panel, which gives nonbinding advice to the agency, voted 20-0 that its biosimilar of etanercept, known as GP201, should be approved in all 5 indications of Amgen’s original drug, which includes rheumatoid arthritis and psoriatic psoriasis.
“We are encouraged by [the] favorable advisory committee recommendation for our proposed biosimilar etanercept,” said Mark McCamish, head of global biopharmaceutical development at Sandoz, Novartis’ biosims unit.
“As a global market leader in biosimilars, we are pleased to move one step closer toward our goal of expanding patient access with our proposed biosimilar etanercept, and look forward to continuing to work with the FDA as they complete their review of our application.”
The original drug made $5.3 billion in 2015 for Amgen ($AMGN), up 14% for the year and its biggest seller. The two have history given that Novartis was the first company to gain a U.S. approval for a biosimilar–for Amgen’s chemotherapy side effects drug Neupogen (filgrastim).
Neupogen made $1.04 billion last year, down 9% year-on-year, coming after the FDA green
light for Novartis’ Zarxio (filgrastim-sndz). The drug was launched last fall at a 15% discount to the original.This comes a day after Amgen was also given a unanimous yes from another FDA panel for its biosimilar of AbbVie’s ($ABBV) Humira (adalimumab)–the biggest-selling drug in the world with $14 billion in sales from 2015. An ongoing patent battle between Amgen and AbbVie, however, could see the launch of the drug delayed by years. The FDA is set to make a final decision on approval by Sept. 25.
And in a reversal of fortune, it’s a similar situation for Amgen and Novartis, with the former also trying to block Novartis from launching GP201. At least 11 other biosimilar versions of Enbrel are currently in the development pipeline, while European regulators have already cleared Samsung Bioepis’ version and are also currently reviewing Novartis’ drug.
