October 3rd 2024
The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.
Medicare Part D Policy on Off-Label Treatments Thwarts Patient Access, Study Says
February 9th 2019A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.
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.
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.
Patients With Pemphigus Vulgaris May Benefit From Early Rituximab
October 14th 2018Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.
Review Documents 15 Years of Experience With Adalimumab in Psoriasis
August 12th 2018This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.
ICER: IL-23 Inhibitors Are Preferable to Anti-TNF Agents for Plaque Psoriasis
August 7th 2018The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.
Rituximab Granted FDA Approval to Treat Pemphigus Vulgaris
June 8th 2018The FDA has approved Genentech’s innovator rituximab (Rituxan) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). This expanded indication makes the drug the first biologic approved for the treatment of PV, a rare autoimmune disease that affects the skin and mucous membranes with progressive blistering.
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.
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).
Humira Competitor Tremfya Gains European Approval for Psoriasis Treatment
November 28th 2017Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Review of Systemic Treatment of Psoriasis Recommends Biologics
November 25th 2017A new review discusses the systemic treatment of psoriasis and recommends biologics and biosimilars for long-term treatment of psoriasis because of their better tolerability and safety compared with other systemic treatments, which are limited largely by poor tolerability and cumulative toxicity.
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.
UK Health Professionals Are Well Informed About Biosimilars
July 6th 2017A survey and drug utilization analysis conducted among UK healthcare professionals found that 75% of respondents were aware that biosimilars were available on their local formularies, and 77% considered biosimilars to be either extremely or very important to save costs for the National Health Service.