Lupin, Mylan get European marketing authorisation for biosimilar Etanerce

Pharma firms Lupin and Mylan NV on Thursday said that they have received marketing authorisation from the European Commission (EC) for Nepexto, a biosimilar etanercept. The EC has granted marketing authorisation for Nepexto for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis, the companies said in a joint statement.

The centralised marketing authorisation applies to all member countries of the European Union, it added. "Nepexto is our first biosimilar to receive regulatory approval in Europe. With this important milestone, we bring an affordable biosimilar to the European market through our partner Mylan," Lupin Ltd CEO Vinita Gupta said.

Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe, providing an effective treatment for multiple therapies including rheumatoid arthritis, she added. Mylan President Rajiv Malik said: "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".

In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets, the statement said. According to IQVIA, Enbrel had sales of approximately USD 9.6 billion globally for the 12 months ending December 2019, it added.

Shares of Lupin Ltd closed at Rs 907.70 on BSE, up 4.69 per cent from its previous close..