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Etanercept was first approved for the treatment of rheumatoid arthritis in Germany in 2000 and since then has offered an effective treatment option for several chronic inflammatory diseases.
A 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.
Mylan and Lupin announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Nepexto® ...