Castleski /
18 July 2016Americas

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.”

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at