ATLANTA – During a public meeting held Tuesday by the Food and Drug Administration (FDA)’s Arthritis Advisory Committee to review the license application of CT-P13, the American College of Rheumatology (ACR) provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the U.S. If approved, CT-P13 [a proposed biosimilar to infliximab (Remicade)] will be the first biosimilar available for the possible treatment of rheumatic disease. Infliximab is currently used to treat rheumatoid arthritis, ankylosing spondylitis (a type of spondyloarthritis) and psoriatic arthritis.
Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and member of the ACR Government Affairs Committee, testified on behalf of the College. Highlights from his remarks include:
- A call for clinical data to ensure safety and efficacy prior to approval and collection of long-term, post-marketing studies of approved biosimilars to monitor for adverse events.
- Reiteration of the ACR’s position that distinct names for biosimilars are needed to ensure correct prescribing and dispensing, post-marketing monitoring of the individual drugs, increased prescriber confidence and enhanced market uptake.
- Advice that the FDA use caution when considering approving extrapolation of biosimilar products for indications where the reference biologic has already been approved in the absence of safety data specific to the biosimilar agent and the patient population in question.
- A call for FDA labeling that indicates whether a biosimilar is interchangeable with the reference biologic; lists all indications for which the biosimilar is approved; and specifies whether supporting clinical data was derived from studies of the biosimilar or the reference biologic.
The safe adoption of biosimilars has been a top legislative priority for the ACR. In March 2015, it released a position statement encouraging scientific study of biosimilars and physician involvement shortly after the FDA’s approval of Zarxio (filigrastim-sndz) for sale in the United States. The organization later applauded the FDA in Aug. 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies.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, 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.
“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,” said Worthing.
“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.”
View Dr. Worthing’s testimony in its entirety >
###The American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to Advance Rheumatology! In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit www.rheumatology.org.