Another FDA approval for a Sandoz biosimilar – this one for Erelzi

Swiss pharma giant Novartis’ (NOVN: VX) subsidiary Sandoz has received US Food and Drug Administration approval for Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

Erelzi is a biosimilar to US biotech major Amgen’s (Nasdaq: AMGN) Enbrel (etanercept), which was originally licensed in 1998. The branded drug brought in sales of $5.56 billion in 2015. Outside the USA and Canada, Enbrel is marketed by Pfizer.

Erelzi is the second biosimilar from Sandoz approved in the USA through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.  Zarxio (filgrastim-sndz) was launched by Sandoz last year as a biosimilar of Amgen's Neupogen (filgrastim).