(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed…
Upadacitinib Promising for RA in Phase 3 Study
In a recent study, upadacitinib proved safe and effective to treat rheumatoid arthritis in patients with inadequate responses to conventional synthetic DMARDs…
Biosimilars Great Debate: To Switch or Not?
SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
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
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?
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…
Secukinumab Meets 5-Year Benchmark for Psoriasis
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
Herpes Zoster & Tofacitinib
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….
Sequential Therapy May Reduce Hip Fracture Risk; Plus New Biosimilar Available in Canada
Patients who receive abaloparatide and switch to alendronate have a statistically significant reduction in fracture risk through 3.5 years, according to a new study…
CMS Implements Part B Modifiers for Biosimilars
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…
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