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Mylan, Lupin Receive EMA For Nepexto, Biosimilar Etanercept

Mylan N.V. (MYL) and Lupin Limited said that the European Commission has granted marketing authorization for Nepexto, a biosimilar to Enbrel or etanercept, for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, 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), 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.

Enbrel had sales of approximately $9.6 billion globally for the 12 months ending December 2019, according to IQVIA.

In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets.

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