Sandoz' biosimilar of Amgen's blockbuster Enbrel has taken a big leap towards US approval after winning unanimous support from regulatory advisors.
The Novartis group is seeking clearance for five indications included in Enbrel's (etanercept) label in the US, targeting autoimmune diseases rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
The US Food and Drug Administration's Arthritis Advisory Committee has voted 20-0 in favour of approving the drug based on evidence from its global development programme showing biosimilar etanercept is highly similar to Amgen's multi-billion-dollar anti-inflammatory.
"We are encouraged by today's favorable advisory committee recommendation for our proposed biosimilar etanercept," said Mark McCamish, Head of Global Biopharmaceutical Development, Sandoz. "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 FDA is not bound to follow the advice of advisory committees but tends to do so. However, even if it does there could be a delay to GP2015's launch in the US, as Amgen is suing Sandoz on grounds that its biosimilar infringes several of Enbrel's patents.
Sandoz' drug is also being reviewed in Europe where the first biosimilar version of Enbrel, made by Samsung Bioepis, was approved in January.