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Second Biosimilar to Remicade Approved
A second biosimilar to infliximab, marketed as Remicade by Johnson & Johnson, has received FDA approval. Infliximab-abda (Renflexis) was developed by Samsung Bioepis/Merck and has been approved for multiple indications.
A second biosimilar to infliximab, marketed as Remicade by Johnson & Johnson, has received FDA approval. Infliximab-abda (Renflexis) was developed by Samsung Bioepis/Merck and has been approved for multiple indications: adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Renflexis is a tumor necrosis factor (TNF) blocker that is delivered as an intravenous infusion. It will be available in single-dose vials of 100 mg. The most common adverse reactions include infections, infusion-related reactions, headache, and abdominal pain. The drug should not be given during an active infection and the warning on the label notes that the incidence of malignancies was greater in patients treated with the TNF blocker compared with the control group.
The drug is contraindicated with anakinra and abatacept. Use of Renflexis with those 2 medications increases the risk of serious infection, according to the drug label. In addition, it has not been studied in children younger than age 6 who have Crohn’s disease or ulcerative colitis.
The biosimilar had been approved almost 2 years ago in South Korea.
Inflectra was the first biosimilar to Remicade that the FDA approved. It was approved April 2016 for multiple indications and it is also administered by intravenous infusion. Inflectra first became available in the United States in November 2016.
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
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What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
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HOPE-CAT Can Identify Maternal Cardiovascular Risk 2 Months Earlier Than Doctors, Study Says
April 25th 2024In a retrospective study, the machine learning tool was able to screen for potential risks of cardiovascular disease nearly 60 days before the patient's medical record showed any signs of a related condition or before they were officially diagnosed or treated for it.
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