FDA approves Sandoz biosimilar

A committee at the US Food and Drug Administration (FDA) has approved a biosimilar application by pharmaceutical company Sandoz.

The product, called etanercept, a biosimilar of Amgen’s drug Enbrel, covers five types of arthritis and psoriasis.

It was unanimously approved by the FDA’s arthritis advisory committee, by 20 votes to 0, on July 13.

The product covers rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Mark McCamish, head of global biopharmaceutical development at Sandoz, said: “We are encouraged by the favourable advisory committee recommendation for our proposed biosimilar etanercept.”