Leading biopharmaceutical companies Celltrion Inc. and Hospira Inc. have received positive opinion from a European Medicines Agency (EMA) Committee to sell its biosimilar versions of Johnson & Johnson’s (NYSE:JNJ) Remicade, a $6 billion arthritis therapy.
The Celltrion-developed Remsima and Hospira-developed Inflectra have received positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CMPH) and are designed to treat rheumatoid arthritis, inflammatory bowel disease, and plaque psoriasis. As a result of this endorsement, the EMA’s CMPH has recommended the granting of marketing authorization approvals for 30 European countries for the first two monoclonal antibody biosimilars. “The CMPH opinions on Remsima and Inflectra will now be sent to the European Commission for adoption of a marketing-authorization decision,” the EMA’s CMPH said in a statement. According to the CMPH, Remsima and Inflectra both contain the same known active substance, infliximab. In the application dossiers, they have been shown to be similar to Johnson & Johnson’s biological medicine Remicade, a monoclonal antibody that has been authorized in the European Union since 1999.
“Remsima and Inflectra are recommended for authorization in the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis,” the CMPH added. So what does this “recommendation for authorization” translate to for medical practitioners and patients? According to Celltrion and U.K.-based Hospira, more affordable treatment. “The price of Remsima will be more than 30 percent cheaper than those of the original drugs,” Kim Hyoung Ki, senior vice president and chief financial officer at Celltrion, told reporters in Seoul today. “We’re confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs,” Hyoung Ki added.