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For the first time, the European Medicines Agency's biosimilars program has recommended approval of a monoclonal antibody. It has given thumbs-up to an alternative formulation of infliximab to treat inflammatory conditions including RA, ankylosing spondylitis, and psoriatic arthritis.
The biosimilars regulatory program of the European Medicine's Agency has approved an alterative formulation of the monoclonal antibody infliximab. It has recommended that the European Union grant final approval for Inflectra, a biosimilar considered therapeutically equivalent to Remicade, for treament of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and inflammatory bowel disease.
Like Remicade, Inflectra is a chimeric human-mouse monoclonal antibody that binds to tumor necrosis factor alpha (TNF-α). Administered by infusion, it can be prescribed either as an adjunct to methotrexate or as monotherapy for patients who cannot tolerate methotrexate. It is the first monoclonal antibody approved by the European agency.
Approval of the drug should offer an opportunity to increase patient access to affordable biologic therapy, said Richard Davies, Senior Vice President and Chief Commercial Officer of Hospira, in a press statement announcing the approval. UK-based Hospira, which owns rights to the drug in Europe, the US, Canada, Australia, and New Zealand, calls itself the world's leading provider of injectable drugs and infusion technologies.
Inflectra was approved by the EC after meeting its primary endpoint of therapeutic equivalence to Remicade in a phase III randomized, double-blind trial. In that study, after 30 weeks of treatment, 73.4% of patients receiving Inflectra achieved >ACR20 improvement scores in symptoms, as against 69.7% of those who took Remicade. Safety and tolerability are similar to Remicade, and common adverse events are viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.
Business analysts predict a rush of European approvals for monoclonal antibody biosimilars to follow this one. The Food and Drug Administration has released draft guidance for manufacturers wishing to apply for approval of biosimilars in the US, and has had conversations with manufacturers about 13 different products, but none has yet been approved. A Hospira spokesman said the company has not set a timeline for applying for FDA approval of Inflectra.