May 16th 2024
Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Paper Questions Utility of DANBIO Results for Switching to Biosimilar Etanercept
February 4th 2019In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.
Providers Not Using Part B Drugs to Add to Profit, Research Finds
February 4th 2019The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.
Review Points to Nocebo Effect as a Cause of Higher Discontinuation Rates for Biosimilars
January 28th 2019In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation have been observed when these studies are compared with blinded switching studies.
Bio-Thera Begins Phase 3 Trial of Proposed Tocilizumab Biosimilar
January 27th 2019Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.
Amgen and Allergan Announce Positive Topline Results for ABP 798
January 24th 2019Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.
Patient Awareness of Biosimilars Impacts Adherence, but Nurse-Led Education Could Help
January 23rd 2019Despite the fact that biosimilars have a longer history in the European Union than in the United States, many European patients still lack awareness of these medicines, and data suggest that a lack of awareness may be keeping patients from adhering to their therapies.
Proposed Biosimilar Shows Similar Glycosylation, Primary Structure, In-Vitro Functionality to Enbrel
January 19th 2019In a recent comparability analysis, a proposed biosimilar to etanercept (that the developers hope to sell as Altebrel) underwent direct comparison to the reference and was found to have a high similarity in terms of glycosylation, primary structure, and in-vitro functionality.
Study Finds that CT-P13 May Be Effective in Takayasu Arteritis
January 17th 2019Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.
Rituximab Biosimilar Is Safe, Effective, and Cost-Saving in RA, but When Will US Patients Benefit?
January 17th 2019When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.
New Treatment Guideline for PsA Recommends First-Line Anti-TNF Biologics
December 5th 2018This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.
EMA to Review Celltrion's Subcutaneous Infliximab Biosimilar
December 4th 2018Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).
After Biosimilar Deals, UK Spending on Adalimumab Will Drop by 75%
November 26th 2018This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.
Anti-TNF Therapy Reduces Glycosaminoglycan Levels in Women With RA
November 22nd 2018Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.
Systematic Review Does Not Find Significant Risk Associated With a Single Switch
November 12th 2018As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.
Autoinjector, Prefilled Syringe Administration of Imraldi Have Similar PK and Safety
November 5th 2018Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.
Rituximab Is Effective in Treating Cutaneous Lupus Erythematosus, Study Finds
October 31st 2018Current treatment for cutaneous lupus erythematosus (CLE) commonly focuses on photoprotection, topical therapies, corticosteroids, antimalarial drugs, and immunosuppressive drugs. More recently, B-cell depleting therapies, such as rituximab, have shown promise in treating systemic lupus erythematosus, though the feasibility of treating CLE with rituximab has not been well described.
As Humira Biosimilars Advance, AbbVie's Upadacitinib Outperforms Adalimumab in Treating RA
October 29th 2018The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.
Secukinumab Expands Label in EU, Approved to Increase Dosing in Treatment of PsA
October 27th 2018Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.
Switching to Biosimilar Etanercept Is Safe and Effective in RA
October 23rd 2018As more biosimilars are earning regulatory approvals in both the United States and the European Union, the question of whether to switch patients (and at what point to do so) continues to be discussed; researchers will present findings from 2 etanercept switching studies in patients with rheumatoid arthritis (RA) during the American College of Rheumatology’s (ACR) Annual meeting, held in Chicago, Illinois October 19-24, 2018.
What Do Providers Need to Know About Biosimilars?
October 22nd 2018With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.
Researchers Present on Immunogenicity of Biosimilar Anti-TNF Agents
October 21st 2018The potential for the development of antidrug antibodies is a key concern among prescribers who use all biologics that target tumor necrosis factor (TNF). Two presentations at the American College of Rheumatology Annual Meeting in Chicago, Illinois, which will be held from October 19-24, 2018, will address the immunogenicity of biosimilars in patients with rheumatoid arthritis and other inflammatory diseases.
Research Focuses on Etanercept Biosimilar SB4, Treatment Retention, and Disease Activity
October 18th 2018As biosimilar etanercept SB4, sold in many markets as Benepali, has entered the rheumatoid arthritis treatment space, researchers have recognized the need to investigate the retention rates and disease activity scores among patients receiving SB4 and its reference.