The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
A retrospective study showed that patients who have rheumatic disease and develop tuberculosis may be able to resume anti-TNF therapy and other biologic agents…
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…
NEW YORK (Reuters Health)—Anti-TNF drugs are more likely to improve growth in children with inflammatory bowel disease (IBD) if they’re given in the earlier stages of puberty, new findings show.¹ Children who achieve remission are also more likely to have satisfactory growth, the research team reported online on Sept. 21 in the Journal of Pediatric…
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…
WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…
LONDON—Results from the extension phase of a Phase 3 trial for the IL-17A inhibitor ixekizumab in psoriatic arthritis (PsA) show that patients started on placebo, adalimumab and ixekizumab continued to show improvements in arthritis, dactylitis and ethesitis, said Philip Mease, MD, a rheumatologist at Swedish Medical Center University of Washington in Seattle.1 Dr. Mease presented the…
NEW YORK (Reuters Health)—Adalimumab reduces the risk of uveitic flare after corticosteroid withdrawal in patients with inactive, noninfectious uveitis, according to results from VISUAL II. “Tumor-necrosis factor (TNF) inhibition, which has been demonstrated to have strong efficacy in rheumatologic disorders, can also have significant role in the management of noninfectious uveitis, even amidst the challenges…