
American College of Rheumatology Responds to Inflectra Approval
The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.
The American College of Rheumatology (ACR) released a statement on April 7, 2016 addressing FDA’s approval of Inflectra (infliximab-dyyb) the
In the statement, ACR says it supports the “safe adoption of biosimilars into the US marketplace.” The college said it “welcomes the introduction of biosimilars into the US healthcare system and is hopefully 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.”
ACR also responded to FDA’s recent
In response, ACR says, “we encourage 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 origins (reference drug versus biosimilar) of clinical data upon which FDA approval is based.” ACR continued to say that it “supports distinct naming and transparent labeling” for all biosimilars.
Some biopharmaceutical companies share ACR’s concerns when it comes to biosimilar labeling. In August 2015, AbbVie submitted a
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