FDA Panel Recommends Approval of Etanercept (Enbrel) Biosimilar

Advisors vote unanimously for five indications

The FDA’s Arthritis Advisory Committee has recommended the approval of GP2015 (Sandoz), a proposed biosimilar etanercept. The panel voted unanimously (20–0) in support of biosimilar etanercept for all five indications of the reference product (Enbrel, Amgen), including rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.

The recommendation was provided after the presentation of data from a global development program, which demonstrated biosimilarity to the reference product. The program included a comprehensive comparison of GP2015 and Enbrel at the analytical, nonclinical, and clinical levels, including data from four pharmacokinetic studies involving a total of 216 healthy volunteers, as well as data from a confirmatory efficacy and safety study of 531 patients with moderate-to-severe chronic plaque psoriasis. The development program also included five nonclinical studies. 

The FDA often seeks the advice of its advisory committees as it reviews and decides whether to approve applications, although the agency does not always follow their recommendations.

Source: Sandoz; July 13, 2016.