Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
Novartis Launches First U.S. Biosimilar Drug at 15% Discount
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…
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 The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
Similar RA Outcomes with Abatacept & Tocilizumab
NEW YORK (Reuters Health)—Clinical outcomes of rheumatoid arthritis (RA) are similar with abatacept and tocilizumab treatment, but the factors that predict efficacy differ for the two agents. “The recommendations for RA treatment from the U.S. and EU describe the use of abatacept and tocilizumab as first-line biologics along with anti-TNF (anti-tumor necrosis factor) inhibitors,” Dr….
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
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…
Rontalizumab May Help Patients with Lupus & Low Interferon Signature
In a Phase 2 study, researchers found that rontalizumab was a more effective treatment in patients with systemic lupus erythematosus who had an interferon signature metric score lower than 1.
Biosimilar Drug Updates Reported from EULAR
At the 2015 meeting of the European League Against Rheumatism in June, multiple studies were presented comparing the use of different biosimilar and biologic drugs in treating rheumatoid arthritis…
Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline
It seems to have begun in Norway, the international pressure to switch patients from well-known brand biologic agents, such as Remicade (infliximab), to biosimilar agents, due to a significant cost advantage.1 This biosimilar came with a 39% price markdown last year compared with the brand, and when Norway called for bids, the discount went to…
Clinical Trials Ongoing for Brodalumab
Brodalumab, an interleukin (IL) 17 inhibitor, is currently in early clinical trials (Phase 1b and Phase 2) for a number of different autoimmune diseases.1 Amgen recently terminated its co-development and commercialization agreement with AstraZeneca for the brodalumab investigational program in trials for moderate to severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Amgen’s decision to…