Posted by Michael Wonder on 13 Jul 2016
Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
13 July 2016 - Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product.
Sandoz, a Novartis division and leader in biosimilars, announced today that the US FDA Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
