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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.
Celltrion elaborated further stating that the European approval for Remsima was remarkably good news for patients who previously had limited access to advanced therapeutics, particularly those hindered by the high cost of antibody biopharmaceuticals. Hospira, which entered into an agreement with the South Korea-based Celltrion in 2009, agrees and under the terms of its arrangement with the company has obtained the rights to Inflectra in Europe, the United States, Canada, Australia, and New Zealand.
“Today’s announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA, and provides the next step toward Inflectra being approved for use in Europe,” said Dr. Stan Bukofzer, Hospira’s corporate vice president and chief medical officer. Hospira added that biologic medicines like Johnson & Johnson’s Remicade have led to vast improvements in the treatment of conditions such as rheumatoid arthritis and inflammatory bowel disease, but in many countries they also represent one of the biggest medical expenditures.
“In a time when there is mounting pressure on healthcare budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards,” said Richard Davies, Hospira’s senior vice president and chief commercial officer.
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