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Articles tagged with "Biosimilars"

ACR-Led Coalition on Underwater Biosimilars Grows, Charts Next Steps

From the College  |  August 5, 2024

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

From the College  |  May 5, 2024

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

From the College  |  April 6, 2024

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

Michele B. Kaufman, PharmD, BCGP  |  March 26, 2024

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

Carina Stanton  |  January 17, 2024

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

Thomas R. Collins  |  January 4, 2024

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

Michele B. Kaufman, PharmD, BCGP  |  November 6, 2023

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

Ruth Jessen Hickman, MD  |  September 7, 2023

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

Michele B. Kaufman, PharmD, BCGP  |  January 31, 2023

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

Michele B. Kaufman, PharmD, BCGP  |  July 13, 2022

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.

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