ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
Methotrexate Halt Feasible in Some Etanercept RA Responders
NEW YORK (Reuters Health)—Certain rheumatoid arthritis (RA) patients doing well on etanercept and methotrexate may be able to quit the latter agent if they have tolerability problems, according to an open-label Canadian study. In a Sept. 11 online paper in Rheumatology, Dr. Boulos Haraoui, of the University of Montreal, and colleagues noted that although combination…
New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising
The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
Guselkumab Studied to Treat RA, Plaque Psoriasis
Guselkumab Studied to Treat RA & Plaque Psoriasis Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). On June 11, 2015, at the 2015 meeting of the European League Against…
Lupus Nephritis Therapies Compared, Plus Naming Guidance for Biosimilars
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…
Resunab Fast Tracked to Treat Scleroderma, Plus, Infliximab Biosimilars in Europe
The FDA has fast-tracked the development of a drug to treat systemic sclerosis, or scleroderma; initial clinical trials started in June. Also, a major hospital group in France has selected the biosimilar infliximab to treat its patients with RA, Crohn’s disease and psoriasis…
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…
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