The European Commission approved Sandoz’s Erelzi® (biosimilar etanercept), a copy of Amgen’s Enbrel®, for all the reference drug’s indications, including rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and nonradiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, and pediatric plaque psoriasis. Erelzi is supplied as a prefilled syringe, with SensoReady®autoinjector pen.
Clearance of Erelzi in Europe was based on a preclinical and clinical development program demonstrating equivalent safety, efficacy, and quality of the biosimilar to Enbrel. Clinical data included results from the 52-week Phase III EGALITY study, which confirmed the comparable safety profiles of Enbrel and Erelzi and showed that switching between the two drugs had no effect on the mean Psoriasis Area and Severity Index.
Carol Lynch, global head, biopharmaceuticals at Sandoz, the Novartis biosimilars operation, said “Immunology is a priority for us, and today's approval of Erelzi, the second in this therapy area in as many weeks, clearly demonstrates our commitment to patients. This can also be seen in the progress we are making in our immunology pipeline with two recent file acceptances in Europe.”
Just over a week ago, Sandoz won EC approval for Rixathon®, a biosimilar of Roche’s rituximab (MabThera®/Rituxan®) monoclonal antibody for all the reference drug’s indications, including specified blood cancers, rheumatoid arthritis, and certain other immunological disorders. In May, the European Medicines Agency accepted for review Sandoz’s marketing authorization applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab).
FDA approved Erelzi back in August 2016, but an ongoing patent lawsuit, instigated by Amgen last year even before the Sandoz drug was cleared by the FDA, is likely to delay the U.S. launch until 2018, according to a reported statement by Sandoz head Richard Francis, earlier this year.
Within the last couple of weeks, the U.S. Supreme Court ruled in favor of Sandoz in a separate biosimilar case against Amgen, which reversed a U.S. Court of Appeals for the Federal Circuit (CAFC) decision forcing Sandoz to wait 180 days before it could launch Zarxio® (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen® (filgrastim).