Canada approves infliximab biosimilar
Health Canada approved Inflectra/ Remsima infliximab from Celltrion Inc. (KOSDAQ:068270) 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) and partner Merck & Co. Inc. (NYSE:MRK). Celltrion and partner Hospira Inc. (NYSE:HSP) will co-market the biosimilar in Canada, but declined to provide a launch time frame. The companies are also still determining a price.
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 Extra, Sept. 10, 2013). ...