India, June 5 -- 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 m...