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ACR Encourages Safe Adoption of Biosimilars During FDA Public Hearing on Biosimilar to Infliximab
During the public hearing by the FDA Arthritis Advisory Committee to review the license application for Celltrion’s CT-P13, a biosimilar to infliximab, the American College of Rheumatology called for continued study of biosimilars and detailed labeling information for these products.
The group also reiterated its position on distinct naming guidelines and urged caution related to extrapolation of these products, according to a press release from the American College of Rheumatology (ACR).
Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and member of the ACR Government Affairs Committee, testified on behalf of the ACR at the Feb. 9 advisory committee hearing in which the committee made a positive recommendation for the approval of CT-P13, a biosimilar to infliximab (Remicade, Janssen).
“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,” Worthing said in the release.
“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. Rheumatologists have been working with biologics for quite some time, and our patients take them for lengthy periods of time to manage their conditions, so we have a unique understanding of the extreme complexities of these medications. Even slight changes in molecular structure could mean that a patient reacts different to the biosimilar than they do to the reference biologic.”
During his testimony, Worthing called for clinical data prior to the approval of biosimilars and the collection of long-term, post-marketing studies following approval. Distinct names for biosimilars were requested, along with labeling to indicate whether a biosimilar is interchangeable with a reference product, lists all of the approved indications and details the clinical data on which approval was based — either from studies of the biosimilar or of its reference product.
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