4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.
The regulatory approval follows the adoption of a positive opinion by the CHMP, which was based on a biosimilarity assessment including pre-clinical and clinical studies demonstrating bioequivalence to Enbrel. In addition, a phase 3 clinical study in patients with moderate to severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity.