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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Biologics/DMARDs

Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD

Reuters Staff  |  

NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…

Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

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FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…

Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?

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As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…

Herpes Zoster & Tofacitinib

Arthritis & Rheumatology  |  

Shingles, also known as herpes zoster (HZ), is a common and sometimes debilitating disease that disproportionately affects elderly individuals and those who are immunocompromised. Patients with rheumatoid arthritis (RA) have a 1.5–2-fold higher risk of developing HZ compared with healthy adults. Treatment with some disease-modifying anti-rheumatic drugs (DMARDs) has been shown to increase this risk….

CMS Implements Part B Modifiers for Biosimilars

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With the advent of biosimilars to the marketplace, the Centers for Medicare and Medicaid Services (CMS) now requires modifiers to identify the manufacturer of a biosimilar/biological product on Part B claims. Modifiers were put in place to provide the CMS with the necessary data needed to track claims payments, as well as the ability to…

FDA Approves First Biosimilar for the Treatment of Cancer

The U.S. Food and Drug Administration  |  

Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment…

Opinion: Help Bring Drug Prices Down

Maarten Boers, MSc, MD, PhD  |  

I read with interest the articles in the June issue of The Rheumatologist pertaining to high drug costs. Simon Helfgott rheuminated on it, and Susan Bernstein, a medical journalist, wrote a two-page article titled “Concerns About Cost.” Both articles were thoughtful summaries of a complex issue, putting large question marks over both initial prices and…