Lupin, Mylan Launch Etanercept Biosimilar in Germany

Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled syringe. Lupin’s announcement also noted that Nepexto is its “first biosimilar to receive regulatory approval in Europe.” As we previously reported, the European Commission granted the marketing authorization for Nepexto on June 4, 2020, after the biosimilar received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).