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Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review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has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development.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…
Guselkumab Improves Active Psoriatic Arthritis
A study showed that guselkumab may decrease symptoms of psoriatic arthritis and improve quality of life in adult patients…
New Test Yields Rapid Infliximab Drug Concentrations
NEW YORK (Reuters Health)—A new test provides rapid infliximab drug concentrations that enable immediate dosing adjustments, researchers from Belgium report. “With this rapid test, our biggest wish is to persuade physicians to now perform and use infliximab measurements also in their own daily clinical practice, as many practical and organizational issues that went along with…
GCA Relapse Possible When Discontinuing Tocilizumab
A recent study found that although patients with giant cell arteritis respond positively to long-term tocilizumab treatment, relapse may occur after discontinuing the medication…
- « Previous Page
- 1
- …
- 19
- 20
- 21
- 22
- 23
- …
- 41
- Next Page »