The FDA is considering a supplemental biologics license application for tocilizumab to treat giant cell arteritis…
Physician’s Choice: Factors That Influence First- & Second-Line Biologic Therapy in RA Patients
In patients with RA, age and higher rates of comorbidity are influential in selecting and changing treatments…
FDA Approves Valeant’s Drug to Treat Plaque Psoriasis
(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…
Switch to Biosimilar Infliximab for IBD Slashes Drug Costs
NEW YORK—Inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab to biosimilar infliximab using a managed-switching program, U.K. research shows. “Thus far, there does not appear to be any significant difference between the two infliximab products in terms of drug persistence, side effects, adverse reactions, disease activity, or blood tests, but ongoing…
Biosimilars to Raise Unique Questions
Rheumatologists are accustomed to educating patients about medications, but biologic medications—and now biosimilars—require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. The first FDA-approved biosimilar to become…
Tips, Resources to Help Rheumatologists Educate Patients on Biologics and Biosimilars
Rheumatologists are accustomed to educating patients about medications—but biologic medications require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. “This includes the patient’s disease activity, prior medications…
Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review
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has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development.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 Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
U.S. Supreme Court to Hear Dispute Over Biologic Drug Sales
NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…
Pfizer Announces Medicare Reimbursement for Inflectra (infliximab-dyyb), the First Biosimilar Monoclonal Antibody Available in the United States
On Jan. 6, Pfizer Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has included payment information for INFLECTRA (infliximab-dyyb), a biosimilar to REMICADE (infliximab), in its January Average Selling Price (ASP) pricing file. This pricing took effect as of January 1, 2017. Additional claims processing information is listed in the MLN Matters…
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