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Carol Eustice

Inflectra (Biosimilar for Rheumatoid Arthritis Drug Remicade) Approved in European Union

By September 14, 2013

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On July 2nd, I blogged that the EMA (European Medicines Agency) recommended approval of two biosimilar drugs. The first biosimilar drug, Inflectra, was approved by the EMA on September 10, 2013. The drug targets tumor necrosis factor (TNF-alpha) and has been approved for the treatment of inflammatory conditions, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and psoriasis.

Phase III clinical trial results revealed that 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in rheumatoid arthritis symptoms after 30 weeks of treatment compared to 69.7% treated with Remicade. Safety and tolerability was deemed equal too.

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