Inflectra/Remsima Infliximab regulatory update
Health Canada approved Inflectra/Remsima infliximab from Celltrion to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The product is a biosimilar of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and partner Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.). Celltrion and partner Hospira will co-market the biosimilar in Canada, but declined to provide a launch time frame. The companies are also still determining a price. The Canadian approval came on Jan. 15. Health Canada approved the product under its subsequent entry biologic (SEB) pathway. According to a 2010 Health Canada guidance document, an SEB can be approved based on a reduced amount of original clinical and non-clinical information, along with supporting information generated using the reference biologic. A Health Canada spokesperson said the agency does not recommend substituting a reference medicine with an SEB.
In September, the partners' infliximab biosimilar became the first biosimilar mAb to gain European approval. Hospira said the biosimilar has been launched in Europe. Celltrion submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for the biosimilar in September (see BioCentury, Sept. 16, 2013). ...