"The Food and Drug Administration (FDA) has announced the approval of Inflectra (infliximab-dyyb), the first biosimilar to receive approval in the U.S. for the treatment of rheumatic diseases, including rheumatoid arthritis and psoriatic arthritis.
"The safe adoption of biosimilars into the U.S. marketplace remains a top priority for the American College of Rheumatology (ACR). Biologics are a lifeline for patients living with rheumatic disease, helping many to avoid pain, long-term disability, and life-threatening complications. Unfortunately, many of our patients struggle to afford these complex therapies due to their high cost.
"The ACR welcomes the introduction of biosimilars to the U.S. healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the U.S. will increase our patients' access to life-changing therapies and improve their overall health.
"While America's rheumatologists support the development of new biosimilar therapies, the safety of our patients remains our highest priority. As such, we encourage the FDA to continue to apply distinct names for future biosimilars, and to maximize clarity in the labeling of biosimilars, specifically with respect to their interchangeable status and the origins (reference drug versus biosimilar) of clinical data upon which FDA approval is based.
"The ACR supports distinct naming and transparent labeling for all biosimilar products to ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence, and enhanced market uptake.
"We will continue to provide input to the FDA as the agency works to bring breakthrough therapies to patients that are clinically appropriate and effective, without compromising patients' health or safety."
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