FDA approves Erelzi (etanercept-szzs) biosimilar for all indications in the reference product.- Sandoz

Sandoz, a Novartis division and the global leader in biosimilars, announced that the FDA approved 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 the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same.

Comment: An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015) and is currently undergoing review.