LONDON/ZURICH (Reuters)—Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first biosimilar copy of a biotechnology drug approved in the U.S., at a discount of 15% to the original. The Swiss drugmaker’s generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen (filgrastim), would…
Search results for: biosimilars
Can We Get Closer to a Cure for RA?
Despite new therapeutics, progress for RA patients has virtually stalled over the past 10 years. In this article, the authors discuss many options to advance to a cure and the evidence for them, including the combination of low-dose methotrexate and anti-TNF; targeting angiogenesis and tissue damage pathways directly; antigen-specific therapy; potential combination of TNF and IL17 blockade; and targeting inhibitory receptors and regulatory T cells.
FDA Warns of Severe Joint Pain Risk with DPP-4 Diabetes Drugs
(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…
FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names
WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
Ustekinumab Found to Be Effective in Adolescents with Psoriasis
NEW YORK (Reuters Health)—Adolescents with moderate to severe psoriasis may respond to the human monoclonal antibody ustekinumab as well as adults, with no unexpected side effects, a new study found. The findings are exciting in part because patients in this age group have limited treatment options, the study’s lead author Dr. Ian Landells, of Memorial…
Epratuzumab Results Disappointing, but Adalimumab Promising
Two Phase 3 trials have shown that epratuzumab did not meet its primary endpoints for treating SLE. Meanwhile, a Phase 3 study has shown adalimumab is effective for treating enthesitis-related arthritis in juveniles…
Biosimilar Drugs for RA Studied in Multiple Trials
Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
EULAR 2015: RA Research Shows Imperfect Guidelines, Suggests Strategies with Biologics
ROME, Italy—Even with classification criteria that have been updated and refined over time, rheumatoid arthritis is still a diagnosis that ultimately has to be made with clinical judgment, said Ronald van Vollenhoven, MD, PhD, professor of medicine and chief of clinical therapy research in inflammatory diseases at the Karolinska University in Sweden. His remarks came…
Adalimumab Remains Safe, Effective for Psoriasis
NEW YORK (Reuters Health)—In adults with chronic plaque psoriasis, adalimumab (Humira, AbbVie) was generally well tolerated and effective during five years of therapy, according to a new analysis. The interim analysis is from ESPRIT, a 10-year multinational post-marketing registry. “Clinical trials are not the real world,” in part because patients with comorbidities are screened out…
Secukinumab Effective for Treating Psoriatic Arthritis
NEW YORK (Reuters Health)—The anti-interleukin-17A monoclonal antibody secukinumab improves signs and symptoms in patients with psoriatic arthritis, according to results from Novartis’ FUTURE 2 trial. In earlier studies, secukinumab has demonstrated superior effectiveness to placebo and etanercept in improving the signs and symptoms of psoriasis. Dr. Iain B. McInnes from the University of Glasgow in…
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