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.
Search results for: biosimilar
Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
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.
The Ethical Tug-of-War Over Biosimilar Adoption
The advent of biosimilar medications has offered the promise of significant cost savings for healthcare systems and patients. Biosimilars are highly similar versions of existing biologic drugs, providing a more affordable alternative once the original biologic patent expires. However, the adoption of biosimilars in the U.S. has been hampered by myriad roadblocks, many of which…
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.
Draft FDA Guidance No Longer Requires Biosimilar Switching Studies
The updated draft guidance, released in June, would accept an assessment of why data provided meet the switching standard to demonstrate interchangeability of biosimilars
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.
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