Sandoz, a Novartis division, announced that the US 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 United States through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
"We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system" said Carol Lynch, Global Head Biopharmaceuticals, Sandoz.
"Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible".
The FDA approval follows a unanimous vote (20-0) by the FDA's Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product. 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.
An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015) and is currently undergoing review.