Study Suggests Majority of Rituximab Use Is Off LabelJuly 2nd 2020
Rituximab was originally approved in the United States in 1997 for treatment of non-Hodgkin lymphoma and has multiple additional approvals for orphan and nonorphan indications. But a recent study found off-label uses now account for more than half of patients receiving rituximab.
Could New Therapies for Macular Degeneration Leave Anti-VEGF Biosimilars Behind?June 24th 2020
The currently available anti–vascular endothelial growth factor (anti-VEGF) therapies for wet age-related macular degeneration (AMD) are costly, but biosimilars in clinical development may ease this problem.
Researchers Take Issue With Methods Used to Arrive at Recommendation Against IBD Nonmedical SwitchingJune 23rd 2020
A joint position statement on biosimilars for the treatment of inflammatory bowel disease (IBD) sparked backlash and criticism over the recommendation against nonmedical switching from reference infliximab to a biosimilar.
Investigators Recommend a More Systematic Effort to Get Biosimilars AdoptedMarch 25th 2020
A gentle, persuasive effort to get patients and physicians to adopt biosimilars is likely to work better than a heavy-handed approach, say Canadian investigators, who recommend more study of how mindsets and prescribing practices are changed.
Editorial Calls for Monitoring of Low-Dose Methotrexate Users for Adverse Events in Light of New RCT DataFebruary 26th 2020
The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.
2019 Saw Mounting Evidence to Support Nonmedical Switching, Review Article SaysFebruary 21st 2020
A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.
Study Finds Similar Pharmacokinetics, Safety of SB4 in 2 Self-Delivery MethodsFebruary 13th 2020
Previous studies demonstrating equivalence of SB4 to etanercept in pharmacokinetics and safety have used pre-filled syringes, but these devices may be difficult for some patients to use if they have reduced hand dexterity due to the challenges of living with rheumatoid arthritis.
What Are the Factors for Starting Anti-TNF Inhibitor Biosimilars in RA and AS?February 11th 2020
The study aimed to provide insight into the real-world patterns of biosimilar initiation in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in Korea by identifying patient characteristics and other factors associated with starting biosimilars using a logistic regression model.
Nocebo Effect May Have Role in Some Treatment Failures, Adverse Events in Nonmedical SwitchingJanuary 29th 2020
Researchers reviewed randomized controlled trials and real-world evidence studies on nonmedical switching; that is, switching patients who are doing well on their current originator therapy to a biosimilar.
Study Suggests CPT-13 Comparable to Infliximab at Lower Cost in Patients With IBDJanuary 18th 2020
The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.
Faster Drug Approvals, Weaker Data? Study Raises Concerns About FDA ProcessJanuary 14th 2020
An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.
ICER Releases Final Report on JAK Inhibitors for Rheumatoid ArthritisJanuary 13th 2020
The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.