Lupin, Mylan launch biosimilar product in Germany

"The approval of Nepexto (etanercept) by the European Medicines Agency (EMA) once again underlines the scientific success of company's biologics programme," Mylan Germany Managing Director Maximilian von Wulfing said. The European Commission had approved the marketing authorisation of Nepexto on June 4, 2020, after the biosimilar received a favourable opinion from the Committee for Medicinal Products for Human Use (CHMP).

New Delhi, Aug 26 (PTI) Drugmaker Lupin on Wednesday said it has in association with Mylan NV launched a biosimilar product Nepexto for the treatment of rheumatoid arthritis in Germany. Nepexto, which has been approved for all therapeutic indications of the reference product Enbrel, is indicated for the treatment of rheumatoid arthritis, severe axial spondyloarthritis and plaque psoriasis.

The product is available as an injectable in an easy-to-use pre-filled pen and a pre-filled syringe. "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," Lupin President EMEA Thierry Volle said in a statement.

Biosimilars like Nepexto will play a vital role in expanding access to effective treatment for multiple therapies, including rheumatoid arthritis, he noted. "The approval of Nepexto (etanercept) by the European Medicines Agency (EMA) once again underlines the scientific success of company's biologics programme," Mylan Germany Managing Director Maximilian von Wulfing said.

The European Commission had approved the marketing authorisation of Nepexto on June 4, 2020, after the biosimilar received a favourable opinion from the Committee for Medicinal Products for Human Use (CHMP). In June 2018, Lupin and Mylan had announced a collaboration to commercialise a biosimilar to etanercept in several global markets.