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Search results for: biosimilars

UHC Formulary Change Impacts Coverage for Ustekinumab

From the College  |  August 23, 2025

Effective Sept. 1, the brand name drug Stelara will no longer be covered on the UnitedHealthcare commercial plan prescription drug list.

Filed under:Drug UpdatesInsurance Tagged with:ustekinumab

FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product

Michele B. Kaufman, PharmD, BCGP  |  July 16, 2025

Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.

Filed under:Biologics/DMARDsConditionsDrug UpdatesPsoriatic Arthritis Tagged with:Biologics & BiosimilarsBiosimilarsFDAFDA approvalPsA Resource CenterPsoriasisPsoriatic Arthritisustekinumabustekinumab-stba

President’s Corner: The ACR Is on Your Side

Carol A. Langford, MD, MHS  |  July 9, 2025

Encouraging lawmakers to pass legislation and promote policies that positively affect rheumatologists, rheumatology care teams and those living with rheumatic disease is one of the most impactful ways the ACR advances its mission. The role of advocacy has never been more critical than in recent months, when we have seen an unprecedented number of executive…

Filed under:From the CollegePresident's Perspective Tagged with:ACR advocacyAdvocacyAdvocates for ArthritisGovernment Affairs CommitteeLegislation & AdvocacyLegislative Action Centerpharmacy benefit managers (PBMs)President's CornerRheumPAC

Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability

Michele B. Kaufman, PharmD, BCGP  |  June 18, 2025

Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.

Filed under:Biologics/DMARDsDrug Updates Tagged with:adalimumabBiosimilarsdenosumabFDA approvalinterchangeabilityU.S. Food and Drug Administration (FDA)

The ACR Calls on CMS, OMB to Reduce Burdensome Healthcare Regulations

From the College  |  June 9, 2025

In response to agency requests for feedback on how to streamline regulations and reduce administrative burden on Medicare program stakeholders and small business owners, the ACR called for the removal of certain regulations related to prior authorization, pharmacy benefit managers and Medicare Part B and Part D access.

Filed under:Legislation & AdvocacyPractice Support Tagged with:ACR advocacyRegulationTrump administration

ACR Executive Committee Holds Meetings with Heads of FDA, CMS

From the College  |  May 17, 2025

As in past administrations, members of the Executive Committee scheduled meetings with leaders of the Food & Drug Administration and Centers for Medicare & Medicaid Services to discuss ACR policy priorities and agency agendas.

Filed under:American College of RheumatologyLegislation & Advocacy Tagged with:ACR advocacyCenters for Medicare & Medicaid Services (CMS)U.S. Food and Drug Administration (FDA)

ACR Monitoring HHS Workforce Reductions, Function Consolidations

From the College  |  April 7, 2025

Changes announced April 1 will cut 10,000 positions at the U.S. Department of Health & Human Services and consolidate many department functions. The ACR is monitoring how these changes may impact regulatory issues of concern to ACR members.

Filed under:GuidanceLegislation & Advocacy Tagged with:ACR advocacyU.S. Department of Health and Human Services (HHS)

President’s Corner: The Practicing Rheumatologist

Carol A. Langford, MD, MHS  |  April 5, 2025

Independent, community-based rheumatologists and rheumatology professionals represent a critical part of the ACR and ARP. My immense respect for clinicians grew while watching my husband, who joined an independent practice after completing rheumatology fellowship. With admiration, I saw how he and his two dedicated partners cared for patients while simultaneously managing overhead and striving to…

Filed under:Practice SupportPresident's Perspective Tagged with:ACR CommitteesAdvocacyPresident's CornerRISE registry

March Updates from the ACR Insurance Subcommittee

From the College  |  March 19, 2025

The Insurance Subcommittee is working on behalf of ACR members to address underwater formulary requirements for biosimilars, mandated switches to biosimilars, evaluation and management downcoding and more.

Filed under:Insurance Tagged with:ACR Insurance Subcommittee (ISC)Biosimilars

How NIH, FDA Nominees May Affect Rheumatology

From the College  |  March 11, 2025

The nominations of Jay Bhattacharya, MD, PhD, as director of the National Institutes of Health and Martin Makary, MD, MPH, for commissioner of the Food & Drug Administration have the potential to significantly impact federally funded healthcare research, federal responses to public health emergencies and federal regulation of drugs and medical devices.

Filed under:From the College Tagged with:federal administration

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