Lupin, Mylan get European nod to market Nepexto for treating arthritis, psoriasis
Mumbai: Lupin Limited and Mylan N.V. have 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 Committee for Medicinal Products for Human Use (CHMP) in March this year, which was based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel. In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed the equivalence of Nepexto to Enbrel in terms of efficacy, safety, and immunogenicity.
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