Questions & Answers
On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Benepali, intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. The applicant for this medicinal product is Samsung Bioepis UK Limited.
Benepali will be available as a 50 mg solution for injection. The active substance of Benepali is etanercept, an immunosuppressant (ATC code: L04AB01). Etanercept is a fusion protein, which preferentially binds to TNF-α and thereby inhibits the biological activity of TNF-α.
Benepali is a biological medicinal product that is similar to the reference product Enbrel (etanercept), which was authorised in the EU on 3 February 2000. Studies have shown that Benepali has a comparable quality, safety and efficacy profile to Enbrel (etanercept).
The full indications are:
Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis 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.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. 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.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).'
It is proposed that treatment with Benepali should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis or plaque psoriasis.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
|Name||Language||First published||Last updated|
|CHMP summary of positive opinion for Benepali||(English only)||20/11/2015|
|INN or common name|
|Therapeutic area||Arthritis, RheumatoidArthritis, PsoriaticPsoriasis|
|Date opinion adopted||19/11/2015|
Samsung Bioepis UK Limited
|Application type||Initial authorisation|