BENEPALI, etanercept biosimilar, anti-TNF

RHEUMATOLOGY – DERMATOLOGY - New medicinal product
Opinions on drugs - Posted on Jun 09 2016

Reason for request


No clinical advantage demonstrated relative to ENBREL.

  • BENEPALI is an ENBREL biosimilar. It has the same indications as ENBREL in adults in rheumatology (rheumatoid arthritis, psoriatic arthritis, radiographic and non-radiographic axial spondyloarthritis) and dermatology (plaque psoriasis).
  • It does not have the paediatric indications of ENBREL: juvenile idiopathic arthritis (JIA) and psoriasis. It does not have a dosage form suitable for paediatric use.
  • The bioequivalence of BENEPALI to ENBREL has been demonstrated in a pharmacokinetic study performed in healthy volunteers and its clinical equivalence was evaluated in patients with rheumatoid arthritis.

Clinical Benefit




Clinical Added Value

no clinical added value


Therapeutic use


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