Press Releases

Rheumatology Community Responds to FDA Approval of Inflectra (infliximab-dyyb), a Biosimilar to Remicade

Statement from Joan Von Feldt, MD, MSEd, President of the American College of Rheumatology:

“The Food and Drug Administration (FDA) announced yesterday 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.”

Jocelyn Givens
404-633-3777, ext. 810
jgivens@rheumatology.org

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The safe adoption of biosimilars is a top priority for the ACR. The ACR recently issued a  position statement on biosimilars that updates and clarifies the ACR’s positions on extrapolation, substitution, notification and labeling. The original position statement was released in March 2015 shortly after the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) in the U.S. The organization later applauded the FDA in August 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies. The guidance, “Nonproprietary Naming of Biologic Products,” would designate separate and distinct, non-proprietary names for originator biologic products, related biological products, and biosimilar products. In December 2015, ACR member Dr. Angus Worthing was invited to testify at a public meeting on the reauthorization of the Biosimilar User Fee ACT (BsUFA), where he expressed the ACR’s support for the legislation and called for performance goals that encourage greater transparency in biosimilar product naming and packaging to ensure patient safety. During a February 2016 Arthritis Advisory Committee hearing, the ACR provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the United States. 

 

 

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The safe adoption of biosimilars is a top priority for the ACR. The ACR recently issued a  position statement on biosimilars that updates and clarifies the ACR’s positions on extrapolation, substitution, notification and labeling. The original position statement was released in March 2015 shortly after the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) in the U.S. The organization later applauded the FDA in Aug. 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies. The guidance, “Nonproprietary Naming of Biologic Products,” would designate separate and distinct, non-proprietary names for originator biologic products, related biological products, and biosimilar products. In Dec. 2015, ACR member Dr. Angus Worthing was invited to testify at a public meeting on the reauthorization of the Biosimilar User Fee ACT (BsUFA), where he expressed the ACR’s support for the legislation and called for performance goals that encourage greater transparency in biosimilar product naming and packaging to ensure patient safety. During a Feb. 2016 Arthritis Advisory Committee hearing, the ACR provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the United States.  

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