May 4th 2024
A review article summarized the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Concentration-Based Tapering of Adalimumab Could Reduce Cost in Treating RA
January 19th 2018An editorial, recently published in Annals of the Rheumatic Diseases, discussed the results of a study that found that an adalimumab (Humira) concentration-based tapering strategy was not inferior to the conservative strategy, conducted over 26 weeks.
Switching to Biologics With Different Mechanisms of Action Reduces Cost in Patients With RA
January 13th 2018Patients with rheumatoid arthritis (RA) who require a change in therapy from anti–tumor necrosis factor inhibitor (anti-TNF) treatments to biologics with a different mechanism of action (MOA) had higher treatment persistence and lower healthcare costs than patients who cycled anti-TNF drugs, resulting in lower healthcare costs per persistent patient among the MOA switchers, a recent study finds.
Novartis Initiates Head-to-Head Trial of Secukinumab Versus Sandoz Adalimumab Biosimilar
January 9th 2018Novartis announced today that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab (Cosentyx) versus a proposed biosimilar adalimumab (referencing Humira and being developed by Sandoz, a Novartis division) in patients with ankylosing spondylitis.
Phase 1 Study Shows Similar PK Between Humira and Proposed Biosimilar M923
January 8th 2018Momenta Pharmaceuticals’ M923, a proposed adalimumab (Humira) biosimilar, showed bioequivalent pharmacokinetics (PK) and similar safety and tolerability to both EU- and US-licensed Humira in healthy subjects, according to findings from a phase 1 study published today in Pharmacology Research and Perspectives.
Policy Differences Among European Nations Affect Biosimilar Uptake
January 5th 2018While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.
Indian Drug Maker Hetero Launches Adalimumab Biosimilar, Mabura
January 4th 2018Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.
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).