EMA Recommends Approval of Samsung Bioepis’ Benepali

The European Medicines Agency has recommended approval of Samsung Bioepis’ autoimmune disease therapy Benepali, a biosimilar of Amgen’s blockbuster Enbrel.

Developed under a joint venture between Samsung Biologics and Biogen, the injectable TNF inhibitor gained extrapolation across multiple indications, including moderate to severe rheumatoid arthritis, progressive psoriatic arthritis when antirheumatics have failed, axial spondyloarthritis, ankylosing spondylitis and moderate to severe plaque psoriasis for patients who cannot handle other existing drugs.

Samsung Bioepis’ submission package included head-to-head Phase 1 and 3 trials that demonstrated an 80.8 percent response rate on Benepali compared with 81.5 percent on Enbrel.

In the U.S., the FDA recently accepted Sandoz’s filing for its Enbrel biosimilar.

Another first, the EMA also backed an orphan medicine for narcolepsy: Bioprojet Pharma’s Wakix (pitosilant). The sleep-disorder drug – a histamine H3 receptor antagonist – offers relief from daytime drowsiness and cataplexy, two key narcolepsy symptoms, the EMA says.