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Search results for: biosimilar

Should Patients with Rheumatic Disease Switch from Biologic to Biosimilar?

Susan Bernstein  |  January 19, 2018

SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…

Filed under:Biologics/DMARDsDrug UpdatesInsuranceMeeting Reports Tagged with:ACR/ARHP Annual MeetingBiologicsBiosimilarsdrug costinsurance

Biosimilars: Still Waiting for Promise to Materialize

Larry Beresford  |  January 17, 2018

During the 2017 ACR/ARHP Annual Meeting, advances in biosimilar treatments were abuzz. However, many speakers noted that the presence of biosimilars on the market has not yet resulted in greater access to treatment and lower drug pricing in the U.S…

Filed under:Biologics/DMARDsDrug UpdatesMeeting Reports Tagged with:2017 ACR/ARHP Annual MeetingACR/ARHP Annual MeetingBiologics & BiosimilarsBiosimilarsdrug pricingDrug Updatesinterchangeability

Biosimilar SB2 May Work as Well as Infliximab for Rheumatoid Arthritis

Lara C. Pullen, PhD  |  January 8, 2018

In a 78-week study examining the interchangeability of infliximab with the biosimilar SB2, the treatments demonstrated long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis. Across all the study’s treatment groups, patients had similar treatment response rates, and the long-term clinical profile of SB2 was comparable with infliximab…

Filed under:Biologics/DMARDsDrug Updates Tagged with:BiosimilarsimmunogenicityinfliximabRheumatoid Arthritis (RA)SB2

Pfizer’s Second Biosimilar of J&J’s Remicade Wins U.S. FDA Approval

Tamara Mathias  |  December 14, 2017

(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed…

Filed under:Biologics/DMARDsDrug Updates Tagged with:BiosimilarsJohnson & JohnsonPfizer Inc.Pfizer's IxifiREMICADE (infliximab)

Biosimilars Great Debate: To Switch or Not?

Susan Bernstein  |  November 17, 2017

SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…

Filed under:Biologics/DMARDsEducation & TrainingMeeting Reports Tagged with:2017 ACR/ARHP Annual MeetingBiologicsBiosimilarsJonathan KayRheumatic DiseaseRoy Fleischmann

Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD

Reuters Staff  |  October 22, 2017

NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…

Filed under:Biologics/DMARDsConditionsDrug UpdatesPediatric Conditions Tagged with:BiosimilarsCrohn's diseaseinflammatory bowel diseaseinfliximabPediatriculcerative colitis

Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?

Vanessa Caceres  |  October 17, 2017

As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…

Filed under:Biologics/DMARDsDrug Updates Tagged with:AC&Radverse eventsAmerican College of Rheumatology (ACR)BiosimilarsBiosimilars in the EUdrugefficacyEuropeEuropean UnionfindingsinterchangeabilityMedicationoutcomepatient carepricingreportRheumatic DiseaserheumatologistsrheumatologySafetyTreatment

Sequential Therapy May Reduce Hip Fracture Risk; Plus New Biosimilar Available in Canada

Michele B. Kaufman, PharmD, BCGP  |  September 27, 2017

Patients who receive abaloparatide and switch to alendronate have a statistically significant reduction in fracture risk through 3.5 years, according to a new study…

Filed under:Biologics/DMARDsDrug Updates Tagged with:abaloparatidealendronateBiologics & Biosimilarsetanerceptetanercept-szzsFractureshiphip fracturehip fracture risk

CMS Implements Part B Modifiers for Biosimilars

From the College  |  September 20, 2017

With the advent of biosimilars to the marketplace, the Centers for Medicare and Medicaid Services (CMS) now requires modifiers to identify the manufacturer of a biosimilar/biological product on Part B claims. Modifiers were put in place to provide the CMS with the necessary data needed to track claims payments, as well as the ability to…

Filed under:Biologics/DMARDsFrom the College Tagged with:BiosimilarsCenters for Medicare & Medicaid Services (CMS)InflectraPart B modifiers for biosimilarsRenflexis

FDA Approves First Biosimilar for the Treatment of Cancer

The U.S. Food and Drug Administration  |  September 14, 2017

Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment…

Filed under:Biologics/DMARDs Tagged with:Avastin (bevacizumab)biosimilar cancer drugCancerMvasi (bevacizumab-awwb)U.S. Food and Drug Administration

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