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Search results for: biosimilars

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.

Filed under:ACR ConvergenceAxial SpondyloarthritisBiologics/DMARDsConditionsDrug UpdatesMeeting ReportsPediatric ConditionsSystemic Lupus Erythematosus Tagged with:ACR Convergence 2023ApprovalsBiosimilarsU.S. Food and Drug Administration (FDA)

ACR Advocacy Staff Outline Victories, Challenges from a Busy Year

Thomas R. Collins  |  November 21, 2023

SAN DIEGO—In an advocacy update session at ACR Convergence 2023, ACR staff described progress in multiple priority areas, including access to care and workforce issues.

Filed under:ACR ConvergenceLegislation & Advocacy Tagged with:ACR advocacyACR Convergence 2023

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.

Filed under:Biologics/DMARDsDrug UpdatesPediatric ConditionsRheumatoid Arthritis Tagged with:BiosimilarstocilizumabU.S. Food and Drug Administration (FDA)

‘Better Equipped to Serve the College’: A Look at CORC Achievements Through the Pandemic

Carina Stanton  |  November 3, 2023

Outgoing CORC Chair Marcus Snow, MD, FACR, and the College look back on the tremendous achievements made during the past three years, including pandemic care guidance, improved patient access to care and direction through new biosimilars choices.

Filed under:Practice ManagementProfiles Tagged with:Committee on Rheumatologic Care (CORC)

Your Invitation Here: Learn How Advocacy Can Help You & Your Practice

From the College  |  October 9, 2023

Learn how ACR staff and volunteers support the interests of the rheumatology community in public policy efforts related to Medicare reimbursement, step therapy reform, drug pricing, supporting the medical workforce and more.

Filed under:ACR ConvergenceLegislation & Advocacy Tagged with:ACR Convergence 2023

FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira

Keri Losavio  |  October 5, 2023

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).

Filed under:Axial SpondyloarthritisBiologics/DMARDsConditionsDrug UpdatesPsoriatic ArthritisRheumatoid Arthritis Tagged with:Humirainterchangeability

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.

Filed under:Drug UpdatesHome Slider Tagged with:adalimumabBiosimilarsRA Resource Center

Expert Guidance from the ACR/ARP Access in Rheumatology Meeting

Glen Rodman  |  July 12, 2023

ACR/ARP Access in Rheumatology—As part of ACR Education Exchange 2023, the ACR/ARP Access in Rheumatology meeting addressed some of the major challenges in coverage and payment that U.S. rheumatology practices face. Speakers included rheumatologists, rheumatology professionals, office managers and CEOs. The first section, Thriving, Not Just Surviving—Keeping Your Rheumatology Practice Solvent, focused on financial management…

Filed under:Meeting ReportsPractice Management Tagged with:Access to careACR Education Exchange 2023financespatient carePractice ManagementTreatment

Expert Guidance from the ACR/ARP Access in Rheumatology Meeting

Glen Rodman  |  June 20, 2023

Speakers addressed major challenges in coverage and payment facing rheumatology practices, including financial management and obstacles to patient access to treatment.

Filed under:Meeting ReportsPractice Support Tagged with:Access in Rheumatologyfinancial planninghealthcare access

Rheumatology Priorities Advanced at Busy AMA House of Delegates Meeting

From the College  |  June 16, 2023

Two ACR-led resolutions on in-office specialty drug dispensing and the proposed NIH Public Access Plan passed the House of Delegates and will become AMA policy.

Filed under:Legislation & Advocacy Tagged with:ACR advocacyAMA House of Delegates (HOD)National Institutes of Health (NIH)research publishing

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