A public meeting was convened earlier this week by the Food and Drug Administration (FDA)’s Arthritis Advisory Committee to review the license application of CT-P13, a proposed biosimilar to infliximab (Remicade) for the treatment of rheumatic disease including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. If approved, CT-P13 would be the first such biosimilar available for sale in the US. At the meeting, the American College of Rheumatology (ACR) additionally offered its recommendations for policy guidelines for the licensing of future biosimilars. The safe adoption of biosimilars has been a key legislative priority for the ACR, in the interest of patient safety.
Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and member of the ACR Government Affairs Committee, commented “As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high costs and patients being able to afford them, so the ACR strongly believes that safe and effective treatment alternatives should be made to available to patients at the lowest possible cost. However, we need to be able to confidently prescribe these therapies to our patients and feel comfortable that proper mechanisms are in place for rheumatologists to monitor patient reactions to prescribed biosimilars.” A news story about the ACR testimony, with link to the transcript of Dr. Worthing’s testimony, may be read here.
Posted on February 11, 2016