The FDA has approved the first interchangeable biosimilars for denosumab.
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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.
Insight into the FDA Approval of Ustekinumab Biosimilar
In late October, the FDA approved the first biosimilar to ustekinumab to treat patients with psoriasis, psoriatic arthritis and other conditions. Ustekinumab-auub is expected to be available in the U.S. by 2025.
ACR Advocates with Payers Against Insufficient Reimbursement for Biosimilars
The ACR is engaging with payers regarding formulary requirements that would leave practices underwater when treating patients with rheumatic diseases.
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.
FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira
On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).
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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