Mylan and Lupin's Enbrel biosimilar approved in Europe

5 June 2020

Mylan (Nasdaq: MYL) and India’s Lupin (BSE: 500257) say the European Commission (EC) has granted marketing authorization for Nepexto, a biosimilar to Amgen’s (Nasdaq: AMGN) 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 pediatric plaque psoriasis.

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

Mylan president Rajiv Malik commented: "The approval of Nepexto, our biosimilar etanercept, is a positive step forward as we work to broaden our biosimilars franchise offerings and do our part to increase access to biologic treatments for patients in many European countries. This milestone reflects a strong scientific program behind Nepexto and commitment by our teams and our partner, Lupin, to bring the product to market as soon as possible. We look forward to launching Nepexto in the second half of this year."

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