Lupin, Mylan receive EUmarketing authorization for Nepexto
Lupin Limited (Lupin) and Mylan N.V. 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 equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity.
The centralized marketing authorization applies to all member countries of the European Union.
Etanercept is an injectable, biologic medicine which inhibits tumour necrosis factor (TNF). Enbrel had sales of approximately US$ 9.6 billion globally for the 12 months ending December 2019.
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