Author Archives: Ana de Barros PhD

The European Commission has approved Sandoz’s biosimilar Zessly (infliximab) to treat all indications of its reference medicine Remicade (infliximab), including ankylosing spondylitis (AS). “The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients,” Richard Francis, CEO of Sandoz,…

Ontario, along with other regions in Canada, will now reimburse Cosentyx (secukinumab) under its public drug program for certain adult patients with ankylosing spondylitis (AS) and active psoriatic arthritis (PsA), Novartis Pharmaceuticals Canada recently announced. In addition to Ontario, Cosentyx will also be available through the public…

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…

Mylan and Fujifilm Kyowa Kirin Biologics are partnering to commercialize a biosimilar to Humira (adalimumab) after obtaining European approval. Humira, developed by AbbVie, is a tumor necrosis factor alfa (TNFα)-inhibitor approved in the U.S. and Europe for the treatment of several chronic inflammatory conditions,  including ankylosing spondylitis.

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…

Coinciding with Spondyloarthritis Awareness Month, the Spondylitis Association of America (SAA) is kicking off a national awareness campaign to educate the public and medical community about the chronic disease. About 1 in 100 people in the United States live with spondyloarthritis (SpA), the name given to a group…

The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Ixifi (infliximab-qbtx), a biosimilar to Janssen Biotech’s Remicade, for all indications approved for the reference product, including ankylosing spondylitis. Like Remicade, Ixifi is a chimeric human-murine monoclonal antibody against tumor necrosis factor (TNF). TNF is involved in…

Novartis has initiated a Phase 4 clinical trial to evaluate the impact of increasing the dose of Cosentyx (secukinumab) to 300 mg. in patients with ankylosing spondylitis (AS) who did not achieve symptom remission after 16 weeks of treatment with 150 mg. The ASLeap trial (NCT03350815)…

In vitro diagnostics and theranostics company Theradiag is partnering with the U.S. biotech company Biogen to provide Lisa Tracker kits for monitoring treatment with Flixabi, a biosimilar of Remicade (infliximab). Like Remicade, which is marketed by Janssen, Biogen’s Flixabi is indicated for the treatment of autoimmune diseases and…

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…