Based on findings from a double-blind, placebo-controlled study evaluating its efficacy and safety, rituximab-arrx has received FDA approval for the treatment of patients with rheumatoid arthritis.
FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved
Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
Executive Order Targets Prescription Drugs & Health Insurance to Promote Competition
On July 9, U.S. President Joe Biden issued an Executive Order designed to promote competition in the U.S. economy. The order includes 72 initiatives related to various aspects of the economy, including prescription drugs and health insurance.1 For prescription drugs, Americans pay more than 2.5 times as much for the same prescription drugs as patients…
Insight into the Biosimilar Prescribing Habits of Rheumatologists
The use of biosimilar treatments is increasing, according to surveys conducted in 2018 and 2020 of rheumatologists from eight countries. In the two-year period, Japan had the largest increase in biosimilar prescriptions, with only 6% of surveyed rheumatologists reporting they prefer prescribing originator biologic agents.
Injection Pen May Reduce Injection Fear Among RA Patients Taking Etanercept Biosimilar
Fear of injection decreased when patients with RA switched from self-administering a treatment biosimilar to etanercept in a prefilled syringe to an injector pen, according to a small observational study.
The Race Is On: Clinical Trials Begin for Agents Biosimilar to Denosumab
As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.
New Clinical Trials for Ustekinumab & Denosumab Biosimilars Begin Recruitment
Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.
UnitedHealthcare Designates Avsola, Inflectra Preferred Infliximab Products
On Feb. 1, UnitedHealthcare enacted a new policy designating Avsola and Inflectra as the preferred infliximab products for UHC commercial plans. ACR leaders have urged UHC to allow existing patients to continue on their current medication.
Biologics in Rheumatology: Revolution & Perspectives
A great deal of progress has been made in the treatment of rheumatic diseases—from glucocorticoid use to the advent of biologic therapies. Gerd Burmester, MD, discussed this progress and the impact of biologics in this year’s Phillip Hench, MD, Memorial Lecture.
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