American College of Rheumatology Responds to Inflectra Approval

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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 first biosimilar approved in the US for the treatment of rheumatic diseases.

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ACR also responded to FDA’s recent draft guidance on the labeling of biosimilars. In the draft guidance, FDA says that information pertaining to clinical trials done on biosimilars should only be included in the products label if it is “necessary to inform safe and effective use by a health care practitioner.” Therefore, biosimilar labels will most frequently contain information from clinical trials completed on the reference biologic.

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 Citizen Petition to FDA discussing the agency’s stance on biosimilar labeling. In the petition, AbbVie said that it might be misleading to include study information from another drug in a biosimilar label without acknowledging the studies were not done on the biosimilar itself.

Source: ScienceDaily