During a recent public meeting held by the FDA’s Arthritis Advisory Committee to review the license application for CT-P13 (Celltrion), a proposed biosimilar to Remicade (infliximab, Janssen Biotech), 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 will be the first biosimilar available for the possible treatment of rheumatic disease. Infliximab is currently used to treat rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and a member of the ACR Government Affairs Committee, testified on behalf of the college. His remarks included a call for clinical data to ensure safety and efficacy before the approval of long-term, postmarketing studies of approved biosimilars to monitor for adverse events.
Worthing reiterated the ACR’s position that distinct names for biosimilars are needed to ensure correct prescribing and dispensing, postmarketing monitoring of the individual drugs, increased prescriber confidence, and enhanced market uptake. He also advised that the FDA use caution when considering approving the 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.
Finally, Worthing called for FDA labeling that indicates whether a biosimilar is interchangeable with the reference biologic; that lists all indications for which the biosimilar is approved; and that specifies whether supporting clinical data were derived from studies of the biosimilar or the reference biologic.
In March 2015, the ACR released a statement encouraging scientific study of biosimilars and physician involvement shortly after the FDA’s approval of filigrastim-sndz (Zarxio, Sandoz) for sale in the U.S. The organization later applauded the FDA in August 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies. The guidance would designate separate and distinct, nonproprietary names for originator biologic products, related biological products, and biosimilar products.
In December 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,” Worthing said.
“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 differently to the biosimilar than they do to the reference biologic.”
Source: American College of Rheumatology (link is external); February 10, 2016.
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