The FDA has issued draft guidance recommending that all biosimilar medications be designated as interchangeable with their reference products upon initial FDA approval. A 60-day review and comment period of the draft guidance is now open, and the ACR will soon be submitting comments.
Search results for: biosimilars
FDA Approves 2 More Denosumab Biosimilars
The FDA as approved the biosimilar treatments denosumab-nxxp (Bildyos) and denosumab-nxxp (Bilprevda) for all indications of denosumab, their reference product, including osteoporosis in postmenopausal women.
ACR-Led Resolutions Supporting Research Funding, Biosimilars Access Advance at Annual AMA House of Delegates Meeting
An ACR-led resolution that calls for the protection of NIH funding and the ability to negotiate indirect costs will become AMA policy, along with several other resolutions supported by the ACR.
Underwater Biosimilars Coalition Shares Results of Practice Survey with Congressional Leaders
This week, the Coalition sent Congressional leadership a letter detailing the results of a recent survey about how underwater biosimilars are impacting physicians’ ability to provide high-quality care. Almost all of the nearly 200 practices queried reported being underwater on several biosimilars, with rituximab and infliximab biosimilars being the most common.
Colin Edgerton, MD, Testifies in Congressional Hearing on Biosimilars
In front of the U.S. House Ways and Means Subcommittee, Dr. Edgerton described how challenges of biosimilar costs threaten patient care and outlined several potential legislative solutions.
Reproductive Health, Biosimilars & More in Focus at SOTA 2025
Reproductive health, biosimilars, IgG4-related disease and much more—five speakers give us a sneak peek into important topics being addressed at the ACR’s 2025 State-of-the-Art Clinical Symposium, April 4–6.
After Coalition Meeting, CMS Leadership Agrees to Closer Look at Underwater Biosimilars
The Underwater Biosimilars Coalition shared with the Centers for Medicare & Medicaid Services concerns about problems arising from the average sales price payment methodology and discussed potential options for addressing these challenges.
ACR-Led Coalition Working Toward Legislative Solutions for Underwater Biosimilars
The Underwater Biosimilars Coalition will meet with the Medicare Payment Advisory Commission to discuss concerns about inadequate reimbursement for certain biosimilars, which has limited beneficiary access to these lower-cost alternative therapies.
ACR-Led Coalition on Underwater Biosimilars Grows, Charts Next Steps
New members include rheumatology state societies, specialty partners in gastroenterology and patient-facing organizations representing digestive and inflammatory diseases. The ACR and coalition partners are strategizing additional steps to ensure practices receive adequate reimbursement for biosimilars.
The ACR to the CMS: What You Need to Know About Biosimilars and G2211
On May 23, Drs. Chris Phillips and Rebecca Shepherd, chairs of the ACR’s Committee on Rheumatologic Care and Insurance Subcommittee, respectively, and members of the ACR’s advocacy staff team met with officials from the Centers for Medicare & Medicaid Services to discuss concerns on underwater biosimilars and restrictions on billing G2211.
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