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.
FDA Approves Riabni, a Rituxumab Biosimilar, to Treat Patients with RA
Based on findings from a double-blind, placebo-controlled study evaluating its efficacy and safety, rituximab-arrx has received FDA approval for the treatment of patients with rheumatoid arthritis.
FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved
Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
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