The US Food and Drug Administration has approved Sandoz’ biosimilar of Amgen’s blockbuster Enbrel.
The drug, called Erelzi (etancerpt), has been cleared for the five indications included in Enbrel’s label in the US, targeting autoimmune diseases rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
The approval follows unanimous support from the regulator’s Arthritis Advisory Committee on the back of evidence from Sandoz’ global development programme, showing biosimilar etanercept is highly similar to Amgen’s multi-billion-dollar anti-inflammatory.
“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,” she added, and said the firm is “committed to bringing Erelzi to the US market as soon as possible”.
The drug is also currently being reviewed in Europe, where the first biosimilar version of Enbrel, made by Samsung Bioepis, was approved in January.
Sandoz is panning to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020.
