Yesterday, Sandoz announced the launch of its etanercept product, Erelzi®, in Canada. Erelzi is a biosimilar to Amgen’s Enbrel®, and is approved for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis. According to Sandoz, Erelzi® “is the only biosimilar approved for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), a condition that affects about one in 1,000 children in Canada.” Sandoz further stated that it “plans to launch three more biosimilars of major oncology and immunology biologics across key geographies by 2020.”
As we have previously posted, litigation is currently pending before the U.S. District Court for the District of New Jersey concerning Sandoz’s application to market etanercept in the United States. Although the FDA approved Sandoz’s aBLA for Erelzi® on August 30, 2016, Sandoz has agreed not to launch its biosimilar until a time point that has not been publicly disclosed.