First Biosimilar Monoclonal Antibody Therapy Approved in Europe

Inflectra was approved for treatment of inflammatory conditions by the European Medicines Agency based on evidence that it was as effective, safe, and tolerable as its reference drug, Remicade.

The European Commission has approved Inflectra (infliximab) for treatment of inflammatory conditions, making the drug Europe’s first biosimilar monoclonal antibody therapy, Hospira announced on September 10, 2013.

Inflectra is a biosimilar version of Remicade developed by Celltrion and marketed by Hospira, and is the first monoclonal antibody to be approved through the European Medicines Agency biosimilars regulatory pathway.

Data from clinical trials suggest that the biosimilar is as effective as Remicade. In a Phase III randomized, double-blind study, 73.4% of patients receiving Inflectra experienced a 20% or greater improvement in their rheumatoid arthritis symptoms after 30 weeks of treatment, compared with 69.7% of patients receiving Remicade. The results also indicated that Inflectra was as safe and tolerable as Remicade, with the most common side effects including viral infections, headaches, upper respiratory tract infections, sinusitis, nausea, and abdominal pain.

"Inflectra offers physicians, patients, and healthcare systems a more affordable treatment option, while maintaining similar quality, efficacy, and safety to its reference product,” Stan Bukofzer, corporate vice president and chief medical officer of Hospira, said in a press release.

The press release also claims that as more biosimilar monoclonal antibody therapies are approved, Europe is expected to save more than $27 billion by 2020, with France, Germany, and the United Kingdom likely to see the largest savings.

Hospira plans to apply for approval of Inflectra in the United States in 2015.