The European Medicines Agency(EMA) Committee for Medicinal Products for Human use has recommended approval of BENEPALI, a biosimilar of etanercept(enbrel) for the treatment of rheumatoid arthritis, psoriatic arthritis, axialspondyloarthritis, and plaque psoriasis. Benepali is a product from Samsung bioepis, a joint venture between Samsung biologics and Biogen. Etanercept is a fusion protein that inhibits the activity of tumor necrosis factor alpha. “Studies have shown that Benepali has a comparable quality, safety, and efficacy profile to Etanercept,” the EMA said in a news release.
The agency recomended Benepali for use either alone of in combination with methotrexate in the treatment of moderate to severe active rheumatoid arthritis, active and progressive psoriatic arthritis in patients who have an inadequate response to disease modifying antirheumatoid drugs(DMARDs)including methotrexate. Benepali is indicated for adults with severe active ankylosing spondylitis who have inadequate response to conventional therapy and for adults with non-radiographic axial spondyloarthritis with objective signs of inflammation who have an inadequate response to nonsteroidal anti-inflammatory drugs. Also for patients with plaque psoriasis.
“If approved, Benepali would be the first biosimilar of Enbrel granted approval in the European Union as well as the first subcutaneous anti-tumor necrosis factor biosimilar there” Biogen notes.