Novartis (NVS) Gets FDA Nod For Biosimilar Version Of Enbrel
Zacks Investment Research | Aug 31, 2016 08:59AM ET
Novartis AG (NYSE:NVS) received a major boost when its generic arm, Sandoz obtained FDA approval for Erelzi, the biosimilar version of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel (etanercept).
The FDA has approved Erelzi for all indications stated in Enbrel’s label – rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).
However, the decision was not unexpected as the FDA’s Arthritis Advisory Committee (AAC) had unanimously voted (20-0) in favor of Erelzi’s approval in Jul 2016.
We remind investors that Erelzi is Sandoz’s second biosimilar to be approved through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
In Sep 2015, Sandoz launched Zarxio in the U.S., the biosimilar version of Amgen’s blockbuster drug, Neupogen. Zarxio became the first FDA-approved biosimilar to be launched in the country. Zarxio was followed by the FDA approval for Pfizer’s (NYSE:PFE) Inflectra, a biosimilar version of Remicade in Apr 2016. It was approved for multiple indications including AS (arthritis of the spine), PsA and chronic severe PsO among others.
Meanwhile, a regulatory application for Erelzi was accepted by the European Medicines Agency in 2015 and is currently under review.
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