November 21st 2024
Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Real-World Data Support the Noninferiority of Biosimilar Filgrastim in Preventing FN
January 26th 2018Zarxio, a biosimilar filgrastim approved in the United States in 2015, was demonstrated to have no clinically meaningful differences from its reference in a randomized clinical trial setting, but data on its effectiveness in preventing febrile neutropenia (FN) a real-world setting have been limited thus far.
Treating Crohn Disease With Anti-TNF Drugs Reduces Mortality Rates
January 25th 2018Although some studies have demonstrated an increased risk of death in patients with inflammatory bowel disease taking corticosteroids, the relationship between death and anti–tumor necrosis factor (anti-TNF) drugs has not been as clear.
ACR Symposium Highlights Approaches to Using Biologics, Biosimilars in RA
January 25th 2018At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).
Trastuzumab Plus Chemotherapy Remains the Preferred Option in Treating HER2-Positive EBC
January 24th 2018In an observational study conducted in Germany that began after the marketing authorization was received for reference trastuzumab in early breast cancer (EBC), researchers were able to analyze outcomes for patients treated with trastuzumab both with and without cytotoxic treatment.
Similar Safety, Efficacy, Immunogenicity Shown for Admelog and Reference Humalog
January 23rd 2018SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.
Physician Survey Reveals "Disconnect" Between Expectations, Feasibility in Bioequivalence Studies
January 22nd 2018Some data that physicians would like to see demonstrated in bioequivalence studies may not be feasible in clinical trials due to the number of patients who would have to be enrolled in the studies.
Study of RA Remission Predictors Supports Treat-to-Target Approach to Combination Etanercept Therapy
January 22nd 2018Targeting sustained and stringently defined clinical remission in patients with moderately active rheumatoid arthritis (RA) receiving full-dose combination therapy with etanercept plus methotrexate before considering dose or regimen changes may help improve the likelihood that patients will remain in clinical remission 1 year after the changes are made.
Can Anti-TNF Therapies Treat Insulin Resistance and Type 2 Diabetes?
January 19th 2018Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.
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.
Review Argues That Same Safety, Efficacy Can Be Expected From Biologics, Biosimilars
January 18th 2018In an expert review, the authors provide transparency about biosimilar production, approvals, risk, and benefits to help improve confidence that the same safety and efficacy can be expected from biologics and their biosimilars.
Study: Using Biologics Early in Patients With Pediatric Crohn Disease Improves Linear Growth
January 17th 2018A newly published retrospective study found that patients who received a combination therapy with infliximab and azathioprine early on had significantly increased linear growth compared to patients whose therapy was stepped up.
Very Low-Dose Rituximab May Be Effective, Could Save Costs in Treating Non-Malignant Diseases
January 15th 2018Rituximab is approved for use in hematological malignancies and in rheumatoid arthritis (RA), but is also used off-label in the treatment of antibody-dependent auto-immunological diseases. In off-label indications, alternative dosing schedules are sometimes used, though no dose-finding trials are available to help guide dosing in such diseases.
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.
Rituximab in Multiple Sclerosis: Better Efficacy, Lower Discontinuation Rates Than Other Treatments
January 11th 2018Rituximab (Rituxan) is more effective and has lower rates of discontinuation than other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis, according to a Swedish study published online in the January 8, 2018, issue of JAMA Neurology.
Intravitreal Bevacizumab Revolutionizing Treatment of Diabetic Retinopathy
January 9th 2018Intravitreal injection of bevacizumab (Avastin) has revolutionized the treatment of diabetic eye disease, and has emerged as an important treatment modality, either as primary or adjuvant therapy for diabetic macular edema and proliferative diabetic retinopathy.
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.
Study Demonstrates Real-World Safety, Effectiveness of Biosimilar Epoetin Alfa for Renal Anemia
January 4th 2018Patients with renal anemia undergoing hemodialysis who were treated for up to 24 months with the intravenous biosimilar epoetin alfa HX575 (Binocrit) showed hemoglobin outcomes equivalent to reference epoetin alfa.
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.
Study: Bevacizumab Should Not Be Withheld in Multifocal Glioblastoma
January 1st 2018Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.
Disability as a More Objective Measure in Inflammatory Bowel Disease
December 30th 2017As the treatment paradigm in inflammatory bowel disease (IBD) has shifted from controlling symptoms to fully controlling disease in order to prevent organ damage and disability, some have argued that disability is a better, more objective measure than quality of life in clinical trials and population studies of IBD.
First Brazilian Study of Adalimumab to Treat Ulcerative Colitis Demonstrates Efficacy and Safety
December 29th 2017Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.
Antidrug Antibodies Common, Significantly Impact Biologic Efficacy
December 28th 2017Antidrug antibodies (ADAs) are commonly found in healthy subjects after a single intravenous dose of infliximab and result in faster clearance of infliximab, shorter elimination time, and lower serum infliximab levels, according to a study published in the September 2017 issue of Drugs in R&D by Eli D. Ehrenpreis, MD.
Extrapolation Framework Can Guide Off-Label Determinations for Biosimilars, Study Argues
December 27th 2017In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.
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.