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ACR responds to FDA draft guidance on biosimilars labeling

April 01, 2016

ATLANTA - "The American College of Rheumatology (ACR) commends the Food and Drug Administration (FDA) for issuing new draft guidance recommending that biosimilar labeling clearly differentiates biosimilars from their reference ("originator") drugs. We also applaud the recommendation to specifically identify the branded biologic upon which the biosimilar is based. The draft guidance is the latest in a series of steps by the FDA to make biosimilar labeling and naming as transparent and specific as possible. This will help ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence, and enhance market uptake.

"The rheumatology community - both patient groups and providers - has long been active in calling for distinct naming of biosimilar products. Biosimilar naming is a topic of great importance to the rheumatology community, since many of our patients rely on the administration of safe and effective biologic therapies to manage their chronic conditions. Physicians must be able to confidently prescribe these therapies to patients and know that proper mechanisms are in place to allow rheumatologists to monitor patients' responses and reactions to biosimilars.

"As such, the ACR supports additional measures that would provide physicians with vital information to assess the safety and efficacy of the biosimilar product. We believe that the clinical trial data for the biosimilar should be included in the labeling, and that the label should specify whether the supporting clinical data for each indication are derived from studies of the biosimilar or the reference biologic.

"The ACR will continue to review the FDA's draft guidance and submit detailed comments in the coming weeks. We look forward to continued dialogue with the FDA as the agency works to bring safe and effective biosimilars to market."
-end-
The safe adoption of biosimilars has been a top legislative priority for the ACR. The ACR recently issued a position statement on biosimilars that updates and clarifies the ACR's positions on extrapolation, substitution, notification and labeling. The original position statement was released in March 2015 shortly after the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) in the U.S. The organization later applauded the FDA in Aug. 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies.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, ACR member Dr. Angus 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. During a Feb. 2016 Arthritis Advisory Committee hearing, the ACR provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the United States.

American College of Rheumatology

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