Industry News

First Enbrel Biosimilar Recommended for Approval in Europe

The EMA has recommended Benepali, an etanercept biosimilar for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis.

By: Megan Brooks

 

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has recommended approval of Benepali, a biosimilar of etanercept (Enbrel, Immunex and Amgen), for treatment of rheumatoid arthritis (RA), psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis.

Benepali is from Samsung Bioepis, a joint venture between Samsung Biologics and Biogen. It will be available as a 50-mg solution for injection.

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 Enbrel (etanercept),” the EMA said in a news release.

The agency recommended Benepali for use in combination with methotrexate for the treatment of moderate to severe active RA in adults who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate. Benepali can be used alone in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate, the EMA said. Benepali is also indicated for severe, active, and progressive RA in adults not previously treated with methotrexate. “Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function,” the EMA said.

In psoriatic arthritis, Benepali is indicated for treatment of active and progressive psoriatic arthritis in adults who fail to respond adequately to DMARDs. “Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease,” the EMA said.

In cases of axial spondyloarthritis and ankylosing spondylitis, Benepali is indicated for treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy, the EMA said.

Benepali is also indicated for adults with severe nonradiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs.

And in plaque psoriasis, the indication is for adults with moderate to severe plaque psoriasis who fail to respond to, who have a contraindication to, or who are intolerant to other systemic therapy, including ciclosporin, methotrexate, or psoralen and ultraviolet A light.

The positive opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union.

“If approved, Benepali could 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 in a news release.


Date: November 20, 2015

Original Source: Medscape.com - First Enbrel Biosimilar Recommended for Approval in Europe (requires login)