CHMP recommends Nepexto a etanercept biosimilar.- Mylan

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis. Nepexto will be available as 25 mg and 50 mg solutions for injection. The active substance of Nepexto is etanercept, an immunosuppressant (ATC code: L04AB01). Etanercept is a fusion protein, which preferentially binds to tumour necrosis factor alpha (TNF-alpha) and thereby inhibits its biological activity. Nepexto is a biosimilar medicinal product from Mylan. It is highly similar to the reference product Enbrel (etanercept), which was authorised in the EU on 3 February 2000. Data show that Nepexto has comparable quality, safety and efficacy to Enbrel.