LONDON (Reuters)—European drugmakers, faced with increasing competition from cut-price copies of complex biotech drugs, cautioned doctors on Thursday to take care when switching patients from an established product to biosimilar version. The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But…
Brodalumab Approved for Plaque Psoriasis
Brodalumab has received FDA approval for treating plaque psoriasis in adults, with a Boxed Warning against prescribing it for patients with a history of suicidal thoughts or behavior…
Infliximab Use Not Tied to Malignancy in Pediatric IBD
NEW YORK (Reuters Health)—Immunosuppressive therapy with infliximab (Remicade) for inflammatory bowel disease (IBD) in pediatric patients is not associated with increased risk of malignancy or hemophagocytic lymphohistiocytosis (HLH), according to a Janssen study. Dr. Jeffrey S. Hyams, who worked on the study, calls the finding “reassuring.” He adds in an email to Reuters Health, “our…
ACR Releases New Position Statements on Site of Service & Compounding
Patient Safety & Site of Service for Biologics Although emphasizing its strong support for the use of biologic agents as necessary treatments for rheumatic diseases, the ACR Board of Directors continues to be concerned about the safe delivery of these agents, given the potential for associated adverse events and infusion reactions. In a position statement…
Certolizumab Pegol Promising for Plaque Psoriasis in Phase 3 Trial
Certolizumab pegol has proved safe and effective for treating patients with plaque psoriasis in a Phase 3 clinical trial…
FDA Considers Tocilizumab for GCA & Piclidenoson Enters Phase 3 Trial for RA, Psoriasis
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…
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