Nav: Home

ACR responds to FDA draft guidance on biosimilars labeling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ATLANTA - "The American College of Rheumatology (ACR) commends the Food and Drug Administration (FDA) for issuing new draft guidance recommending that biosimilar labeling clearly differentiates biosimilars from their reference ("originator") drugs.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 The draft guidance is the latest in a series of steps by the FDA to make biosimilar labeling and naming as transparent and specific as possible.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"The ACR will continue to review the FDA's draft guidance and submit detailed comments in the coming weeks.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."
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(FDA) approved filgrastim-sndz (Zarxio) in the U.S. The organization later applauded the FDA in Aug. 2015 for issuing draft guidance requiring separate distinct names for biosimilars and biologic therapies.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

Related Rheumatology Articles:

New guideline aims to reduce infections in total hip & knee replacement patients
According to a new guideline released by the American College of Rheumatology (ACR) and American Association of Hip and Knee Surgeons (AAHKS), the risk of joint infection resulting from total hip and knee replacements can be reduced with careful management of anti-rheumatic medications during the perioperative process.
Biosimilar concerns of rheumatology patients being addressed by national program
To address the fear and insecurity expressed by rheumatology patients on being switched from a biologic to a biosimilar treatment for their arthritis, the Danish Rheumatism Association has participated in a national program designed to ensure patients received independent information about biosimilars, along with closer monitoring of prescriptions to provide reassurance about their safety.
Trial demonstrates benefits of learning sessions for managing rheumatoid arthritis
A new study found that group-based quality improvement sessions help rheumatologists care for rheumatoid arthritis patients with the recommended 'treat to target' (TTT) approach to care.
ACR announces 2017 health policy priorities
The American College of Rheumatology today announced its 2017 health policy priorities, providing detailed policy recommendations to improve access to care for rheumatology patients and address the national rheumatology workforce shortage.
ACR: AHCA does not go far enough to help Americans with rheumatic diseases
American College of Rheumatology President Sharad Lakhanpal, MBBS, M.D., released a statement this morning expressing concern about the American Health Care Act's (AHCA) proposed tax credits system and its failure to include a repeal of the Independent Payment Advisory Board.
'Arthritis 101' Congressional briefing discusses $128 billion impact to healthcare system
Experts from the American College of Rheumatology (ACR) and the Arthritis Foundation today held an 'Arthritis 101' Congressional briefing to educate new and returning Congressional leaders about arthritis and its impact on constituents and the US healthcare system.
Rheumatology leaders say FDA biosimilar interchangeability guidance a balanced approach
The Food and Drug Administration (FDA) has released a draft guidance on biosimilar interchangeability titled 'Considerations in Demonstrating Interchangeability With a Reference Product' that leaders at the American College of Rheumatology (ACR) believe may address many of the safety and efficacy concerns physicians have raised over the past year.
ACR sends letter to Congress outlining health care reform priorities
The American College of Rheumatology sent a letter to Congressional leaders ahead of actions on health policy, urging lawmakers to adopt a health-care reform plan that is consistent with the ACR's priority of affordable and accessible health care for Americans living with rheumatic diseases.
ACR applauds FDA guidance requiring distinct names and suffixes for biosimilars
The American College of Rheumatology today applauded final guidance from the Food and Drug Administration recommending distinct suffixes for biosimilars and reference biologics, which rheumatologists say will be critical to ensuring patient safety and prescriber confidence in the era of biosimilars.
Rheumatology community applauds CMS's decision to scrap Part B payment demo
The American College of Rheumatology today applauded the decision from the Centers for Medicare & Medicaid Services (CMS) not to go forward with the agency's controversial Part B payment proposal, noting that the hard-fought outcome is good news for rheumatology patients who rely on Medicare Part B to access life-saving biologic therapies.

Related Rheumatology Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Don't Fear Math
Why do many of us hate, even fear math? Why are we convinced we're bad at it? This hour, TED speakers explore the myths we tell ourselves and how changing our approach can unlock the beauty of math. Guests include budgeting specialist Phylecia Jones, mathematician and educator Dan Finkel, math teacher Eddie Woo, educator Masha Gershman, and radio personality and eternal math nerd Adam Spencer.
Now Playing: Science for the People

#518 With Genetic Knowledge Comes the Need for Counselling
This week we delve into genetic testing - for yourself and your future children. We speak with Jane Tiller, lawyer and genetic counsellor, about genetic tests that are available to the public, and what to do with the results of these tests. And we talk with Noam Shomron, associate professor at the Sackler School of Medicine at Tel Aviv University, about technological advancements his lab has made in the genetic testing of fetuses.