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…
FDA Officials Discuss Extrapolation & Confusion Around Pediatric Therapies
A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.
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The updated draft guidance, released in June, would accept an assessment of why data provided meet the switching standard to demonstrate interchangeability of biosimilars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.
Commercial Payers Update Reimbursement for Underwater Infliximab Biosimilars
Three commercial health insurance payers have increased reimbursement for infliximab biosimilars in response to concerns that formulary requirements are leaving practices underwater.
UnitedHealthcare Updates Reimbursement for Infliximab Biosimilars
On April 1, UnitedHealthcare updated reimbursement for infliximab biosimilars in response to concerns that formulary requirements are leaving practices underwater.
FDA Proposal for Biosimilar Use in 2025 Budget
A proposal for biosimilar use in the 2025 budget would allow substitution of any biosimilar for its reference product without an interchangeable designation. The hope is to increase biosimilar uptake, with the subsequent potential to increase product “competition, access and affordability.”1 In the 2025 budget proposal, the Biden administration noted that the legal distinction between…
- 1
- 2
- 3
- …
- 12
- Next Page »