Etanercept biosimilar receives positive CHMP opinion
medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new etanercept biosimilar for the treatment of a number of rheumatic diseases.
The biosimilar, marketed under the brand name of Nepexto, has been shown to have similar safety and efficacy profiles to originator etanercept, and will be available as 25 mg and 50 mg solutions for injection.
As with the originator, the biosimilar is recommended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and juvenile plaque psoriasis.
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