BENEPALI, etanercept biosimilar, anti-TNF

RHEUMATOLOGY – DERMATOLOGY - New medicinal product

Opinions on drugs - Posted on Jun 09 2016

Inclusion

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.

Substantial	-
Insufficient

no clinical added value

Therapeutic use

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