www.fdanews.com/articles/197453-mylan-and-lupin-receive-european-clearance-for-etanercept-biosimilar
Mylan and Lupin Receive European Clearance for Etanercept Biosimilar
June 5, 2020
The European Commission (EC) has approved Mylan’s and Lupin’s Nepexto, a biosimilar to Amgen’s Enbrel (etanercept) for all the same indications.
The approval was based on a biosimilarity assessment that demonstrated bioequivalence to Enbrel. In addition, a phase 3 trial in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel for safety, efficacy and immunogenicity.
The EC has approved Enbrel for several indications, including rheumatoid arthritis, plaque psoriasis and axial spondyloarthritis.