Lupin and Mylan announced the launch of Nepexto, biosimilar etanercept, in the German market. Nepexto is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis from the age of two years, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents from the age of six years. Nepexto is approved for all therapeutic indications of the reference product Enbrel.
The Tumor Necrosis Factor (TNF) inhibitor 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. Nepexto is available as a solution for injection in a pre-filled pen and pre-filled syringe.
“Nepexto, with equivalent efficacy and safety to reference product Enbrel, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. The European Commission approved the marketing authorization of Nepexto on June 4, 2020, after the biosimilar received a favourable opinion from the Committee for Medicinal Products for Human Use (CHMP). The CHMP concluded that the development program including analytical, functional, clinical and immunogenicity data, demonstrated biosimilarity with its reference product, Enbrel,” informed the companies through a statement.
Thierry Volle, President, EMEA, Lupin said, “We are excited to bring Nepexto in Germany. Nepexto is our first biosimilar to receive regulatory approval in Europe. This launch is a remarkable milestone for our biosimilar group and we are glad that we are able to bring an affordable biosimilar to the European market through our partner Mylan. Biosimilars like Nepexto will play a vital role in expanding access to effective treatment for multiple therapies including rheumatoid arthritis.”
Dr Maximilian von Wülfing, Managing Director of Mylan Germany said, “Germany is the first country in Europe to introduce Nepexto, the etanercept from Mylan. The approval of Nepexto (etanercept) by the European Medicines Agency (EMA) once again underlines the scientific success of Mylan’s biologics program. To date, Mylan has launched and commercialised four biosimilar products in Germany, two in immunology and two in oncology. Mylan offers a comprehensive and diverse biologics pipeline, and we want to make as many of these complex drugs as possible available to patients in Germany.”
Nepexto is the second immunology product to be introduced into the German market.