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Search results for: biosimilars

Drug Pricing Bills Move Forward

Angus Worthing, MD, FACP, FACR  |  September 20, 2019

This week, the U.S. House of Representatives released a long-anticipated plan that contains provisions to reduce U.S. drug prices according to an international price index.

Filed under:Drug Updates Tagged with:drug pricingLegislation

FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)

Michele B. Kaufman, PharmD, BCGP  |  September 16, 2019

Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…

Filed under:Biologics/DMARDsDrug Updates Tagged with:adalimumab-bwwdFDAFDA approvalHadlimaU.S. Food and Drug Administration (FDA)

Updates to Axial Spondyloarthritis Guideline

Carina Stanton  |  September 5, 2019

A 2019 update of the ACR’s previous clinical practice guideline on axial spondyloarthritis is now available online. Lead investigator Michael Ward, MD, shares advice for implementing the guideline updates, including those related to sequencing and tapering biologics, and knowing when to obtain images.

Filed under:Axial SpondyloarthritisClinical Criteria/Guidelines Tagged with:Ankylosing SpondylitisAS Resource Centeraxial spondyloarthritis (SpA)Clinical GuidelinesMichael Ward

Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis

Mary Choy, PharmD, BCGP, FASHP  |  August 16, 2019

Over the past few years, bio­similars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…

Filed under:ConditionsDrug UpdatesRheumatoid Arthritis Tagged with:abataceptadalimumabanakinrabaricitinibCertolizumab PegoletanerceptGolimumabinfliximabrituximabsarilumabtocilizumabTofacitinib

Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel

Deena Beasley  |  August 12, 2019

(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….

Filed under:Biologics/DMARDsDrug Updates Tagged with:AmgenBiologicsBiosimilarsetanerceptetanercept-szzsLegalNovartis

Samsung Bioepis Humira Biosimilar Wins FDA Approval

Aakash Jagadeesh Babu and Bernard Orr  |  July 30, 2019

(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…

Filed under:Biologics/DMARDsDrug Updates Tagged with:AbbVieFDA approvalHadlimaHumira biosimilarsMerck & Co Inc.Samsung Bioepis Co. Ltd

New Wins, Ongoing Challenges for ACR Insurance Subcommittee

Carina Stanton  |  July 3, 2019

Corrections to reimbursement system errors with Aetna and a Medicare contractor demonstrate the latest wins for all providers by the ACR’s Insurance Subcommittee. But the committee remains hard at work advocating for rheumatologists on several fronts.

Filed under:Billing/CodingLegislation & AdvocacyProfessional Topics Tagged with:AdvocacyAmerican College of Rheumatology (ACR)Dr. Chris PhillipsHealth InsuranceMeredith Strozier

ACR Hill Visits Yield Key Bill Support; Plus Medicare, Biosimilar Wins

Angus Worthing, MD, FACP, FACR  |  May 20, 2019

Greetings from Washington, D.C., where ACR leaders just held more than 100 meetings on Capitol Hill supporting reforms to step therapy and prior authorization, increased reimbursement for dual-energy X-ray absorptiometry (DXA), solutions to the rheumatology workforce shortage, and rheumatology-specific research at the Pentagon. We’re already hearing great news about our successes: Hours after our visit,…

Filed under:American College of RheumatologyLegislation & AdvocacyMeeting Reports Tagged with:ACR Capitol Hill visitAdvocates for ArthritisBiosimilarsmedical school loansMedicareMedicare Reimbursementpharmacy benefit managers (PBMs)Safe Step Act of 2019 (H.R. 2279)step therapy reform legislation

MicroOne / shutterstock.com

Rheumatology Drugs at a Glance, Part 2: Psoriasis

Mary Choy, PharmD, BCGP, FASHP  |  May 17, 2019

Over the past few years, bio­similars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug option; others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and other medications used to…

Filed under:ConditionsDrug Updates Tagged with:adalimumabapremilastbrodalumabCertolizumab Pegoletanerceptguselkumabguttate psoriasisinfliximabinverse psoriasisixekizumabpsoriatic arthritispsoriatic erythrodermapustular psoriasisRheumatic Drugs at a Glancesecukinumabtildrakizumabustekinumabvulgar psoriasis

IBD Patients Who Switch from Infliximab to Biosimilar See Mixed Results

Will Boggs MD  |  April 22, 2019

NEW YORK (Reuters Health)—Patients with inflammatory bowel disease (IBD) can safely switch from infliximab to the biosimilar CT-P13, though they may face a higher risk of clinical relapse, researchers from Spain report. Recent studies have demonstrated the effectiveness and safety of infliximab biosimilars in patients with IBD, but there are limited data about the effectiveness…

Filed under:Biologics/DMARDsDrug Updates Tagged with:biosimilar CT-P13inflammatory bowel disease (IBD)infliximabinfliximab biosimilar

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