November 19th 2024
The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Study: Switching to Biosimilar Infliximab Does Not Affect Phosphorylation Levels
January 3rd 2018A new study used flow cytometry to compare phosphorylation levels of intracellular epitopes in peripheral blood mononuclear cells from patients with psoriasis in clinical remission who were treated with reference infliximab versus healthy controls, and further evaluated whether a switch from reference infliximab to biosimilar CT-P13 affected intracellular phosphorylation patterns.
SB5 Shows Equivalent Response Rate to Humira in Patients With Rheumatoid Arthritis
January 3rd 2018A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).
Phase 3 Study Shows Similarity of LBEC0101 to Reference Etanercept
January 3rd 2018A newly published study evaluating LG Chem's proposed biosimilar etanercept in comparison with its reference (Enbrel) found that LBEC0101 had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and that the proposed biosimilar was well tolerated.
Dr Marcus Snow: 2017 Saw Increased Familiarity With Biosimilars, But Not Increased Uptake
December 26th 2017According to Marcus Snow, MD, assistant professor of internal medicine in the division of rheumatology, University of Nebraska Medical Center, some of the most critical developments in the biosimilars space during 2017 were the result of payer decisions.
Biologic Treatment in Patients With Axial Spondyloarthritis and Low Disease Activity
December 26th 2017A Polish study of axial spondyloarthritis patients who discontinued treatment with anti–tumor necrosis factor (anti-TNF) therapy because of low disease activity found that more than half eventually needed to restart anti-TNF therapy.
Study: Further Post-Marketing Research Warranted for Infliximab and Its Biosimilars
December 23rd 2017The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.
Death in Phase 3 Study Dampens Positive Top-Line Data for Upadacitinib
December 21st 2017AbbVie reported on Wednesday that a phase 3 trial of its upadacitinib as monotherapy for rheumatoid arthritis (RA) met all of its primary and key secondary endpoints, giving more momentum to the drug that appears poised to help AbbVie retain its share of the RA market after adalimumab biosimilars launch in the United States. However, a death reported during the trial raises renewed concerns about the safety of the Janus kinase inhibitor.
Fresenius Kabi Submits Adalimumab Biosimilar Marketing Application to EMA
December 19th 2017Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).
Study: Starting Dose, Cumulative Dose Do Not Predict Rituximab Adherence in RA
December 14th 2017A recently published study explored the impact of 2 different initial doses and a cumulative 2-year dose of rituximab on drug adherence and predictors of adherence to treatment in patients with RA in an observational clinical setting.
Researchers Find Low Infection Risk With Denosumab Plus Other Biologics
November 29th 2017A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.
Study Finds High Rates of Switching, Discontinuation of Biologics Among Patients With AS
November 28th 2017Patients with ankylosing spondylitis (AS) may benefit from biologic therapies, including anti–tumor necrosis factor (anti-TNF) treatments including adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade or its biosimiars, Inflectra and Renflexis).
Switching to CT-P13 Associated With Loss of Response in Patients With Behçet's Disease
November 22nd 2017A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.
NHS: Biologics Benefit Children With Plaque Psoriasis, But Cost-Effectiveness Uncertain
November 20th 2017A recent Health Technology Assessment (HTA) report by the United Kingdom’s National Institute for Health and Care Excellence (NICE) concludes that adalimumab, etanercept, and ustekinumab improve the symptoms of psoriasis in children and young people in the short term, but the cost-effectiveness of these medications requires further study.
European Commission Grants Marketing Authorization For BI's Adalimumab Biosimilar
November 13th 2017Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission to treat multiple rheumatic diseases after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2017.
New Online Consultation Tool Empowers Patients With Rheumatic Diseases, Study Finds
November 9th 2017Chinese researchers employed a new online consultation tool to improve disease management for patients with rheumatic diseases who travel long distances for a consultation with their rheumatologist and noted significant savings for the patients.
Research Presented on 4 Proposed Etanercept Biosimilars
November 9th 2017Four presentations on Monday at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research comparing reference etanercept to 4 proposed biosimilars: SB4, LBEC0101, CHS-0214, and GP2015.
BI Announces 1-Year Data on Adalimumab Biosimilar, Cyltezo
November 8th 2017At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).
Obese Patients With Rheumatoid Arthritis Less Likely to Achieve Remission
November 8th 2017Research presented at the 2017 American College of Rheumatology Annual Meeting found that patients with rheumatoid arthritis and higher body mass index were less likely to achieve remission and more likely to face higher rates of disability.
4 Studies Address Successes, Failures, and Strategies in Non-Medical Biosimilar Switching
November 8th 2017Today, 4 presentations at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research on switching studies concerning etanercept and infliximab biosimilars.
Biosimilars Present Distinct Challenges in Rheumatology Practice
November 7th 2017In a presentation titled “Biosimilar Medicine: Changing Landscape in Health Care,” given on Monday at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, J. Eugene Huffstutter MD, FACP, FACR, shared practical considerations for using biosimilars in the rheumatology clinic.
Research Focuses on Proposed Adalimumab Biosimilars
November 6th 2017Three presentations at this week’s 2017 American College of Rheumatology Annual Meeting in San Diego, CA, cover research on pharmacokinetic equivalence, safety, and switching of 2 proposed adalimumab biosimilars, GP2017 and CHS-1420.
2 Surveys Highlight Rheumatologists' Knowledge Gaps With Biosimilars
November 6th 2017Two posters presented today at the American College of Rheumatology’s 2017 meeting in San Diego, California, highlight the gaps in US rheumatologists’ knowledge concerning biosimilar therapies, and underscore the importance of greater physician education about biosimilar medicines.