Diagnosing rheumatoid arthritis (RA) early in the disease process is ideal, because treatments are more likely to be effective and less damage will occur. Guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) state that using newer biologic medications, in addition to more aggressive dosing of traditional medications, is…
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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 The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
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…
First Biosimilar Drugs Approved in U.S., Canada
The first biosmilar products have been approved in the U.S. and Canada, following Europe’s early lead. Canada approved its first biosimilar monoclonal antibody (mAb) therapy, known as Inflectra (infliximab), on March 30, 2015.1 In Canada, biosimilars are being called subsequent entry biologic (SEB) agents. Inflectra is approved for treating patients with rheumatoid arthritis (RA), ankylosing…
The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market
With the U.S. FDA’s first approval of a biosimilar drug earlier this month, rheumatologists stress the need to ensure safety, efficacy of such drugs in treating rheumatic diseases