American College of Rheumatology Praises Approval of Second US Biosimilar


Inflectra biosimilar treats conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

The American College of Rheumatology (ACR) issued an official statement on the FDA’s approval of the biosimilar drug infliximab-dyyb (Inflectra) for the treatment of rheumatic diseases.

Inflectra is the second biosimilar to be approved in the United States.

“The safe adoption of biosimilars into the US marketplace remains a top priority for the American College of Rheumatology,” the ACR said in the statement. “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.”

Currently, the approval process for biosimilars has been slow and it will be a long time before they have an impact on high drug prices. However, the safety of patients remains the top concern of the ACR.

Inflectra is indicated for adults and pediatric patients (6-years-old and up) with moderate-to-severe active Crohn’s disease and adults with severe ulcerative colitis who had an inadequate response to conventional therapy; those with moderate-to-severe active rheumatoid arthritis in combination with methotrexate; those who have ankylosing spondylitis; those with active psoriatic arthritis; and adults with chronic severe plaque psoriasis.

“While America's rheumatologists support the development of new biosimilar therapies, the safety of our patients remains our highest priority,” the ACR said. “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.”

The approval of Inflectra, which is administered by intravenous infusion, came from evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data that shows Inflectra is biosimilar to Remicade.

“The ACR welcomes the introduction of biosimilars to the US healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the US will increase our patients' access to life-changing therapies and improve their overall health,” the ACR wrote. “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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