The updated draft guidance, released in June, would accept an assessment of why data provided meet the switching standard to demonstrate interchangeability of biosimilars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…
The Biosimilar Economic Conundrum: Where We Stand
Reimbursement has fallen below acquisition price for some biosimilar versions of infliximab, forcing practices and patients to make difficult decisions. The ACR is working to change this.
Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals
An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
FDA Approves New Biosimilar for Adult & Pediatric Arthritis
This year, tocilizumab biosimilars have been approved to treat adult and pediatric patients with rheumatic disease, including rheumatoid arthritis, juvenile idiopathic arthritis and more, in both Europe and the U.S.
Marching to the Biosimilar Beat: Questions on Rollout Remain
The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.
First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles
After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.
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