Author Archives: Ana de Barros PhD

Lupin Seeks EU Marketing Approval for YLB113, Etanercept Biosimilar, for Ankylosing Spondylitis

The European Medicines Agency has accepted for review Lupin‘s marketing authorization application for YLB113, a biosimilar of etanercept that is marketed by Amgen under the brand name Enbrel. YLB113’s application is for the treatment of ankylosing spondylitis, axial spondyloarthritis, and non-radiographic axial spondyloarthritis, as well as rheumatoid and psoriatic arthritis…

4 More Canadian Provinces Add Erelzi to Public Drug Plans for Inflammatory Diseases

The Canadian provinces of Manitoba, Saskatchewan, Alberta, and Newfoundland have joined others in adding Sandoz’s biosimilar Erelzi (etanercept) to provincial drug plans for the treatment of multiple inflammatory diseases including ankylosing spondylitis. A biosimilar of the reference medicine Enbrel, Erelzi is a tumor necrosis factor (TNF)-alpha inhibitor, which means…

European Commission Approves Cyltezo, Humira’s Biosimilar, for Chronic Inflammatory Diseases

Boehringer Ingelheim announced that the European Commission has granted marketing authorization for Cyltezo, a biosimilar to Humira (adalimumab), for the treatment of ankylosing spondylitis (AS) and other chronic inflammatory diseases in adults and children. The decision follows Cyltezo’s approval by the U.S. Food and Drug Administration (FDA) in August 2017…