FDA Approves Sandoz’s Erelzi as Biosimilar to Amgen’s Enbrel

The U.S. Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs), the first biosimilar etanercept, for all indications included in the reference product’s label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. This is the third of four biosimilars approved in the U.S. and the second manufactured by Sandoz.

FDA approval is based on a comprehensive package of analytical, nonclinical and clinical data confirming that Erelzi is highly similar to the U.S.-licensed reference product, Amgen’s Enbrel. Clinical studies included four comparative pharmacokinetic 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.

“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 of biopharmaceuticals for Sandoz. “Sandoz is proud to have developed two of the [four] biosimilars that are currently FDA-approved, which further demonstrates our commitment to U.S. patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the U.S. market as soon as possible.”

An application for Sandoz biosimilar etanercept was accepted by the European Medicines Agency in the fourth quarter of 2015 and is currently undergoing review.