FDA Proposal for Biosimilar Use in 2025 Budget

In the case of potential initiation of new biologic therapy, patient-specific factors are considered. If the appropriate medication has a biosimilar available, the ACR supports initiating treatment with a biosimilar.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

FY25 legislative proposals. U.S. Food & Drug Administration. 2024 Mar 11.
Fan C. Comparison of Humira biosimilars in the US and Europe. Pharmaceutical Technology. 2023 Mar 24.
Biosimilars. American College of Rheumatology Position Statement.

After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…

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.

The use of biosimilars for rheumatology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

References

The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety

Biosimilars Debate Heats up over Cost Savings, Safety Concerns

Marching to the Biosimilar Beat: Questions on Rollout Remain

Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

References

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