ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
Search results for: infliximab
Health Plans Enact Coverage Policies for Remicade & Infliximab Biosimilars
Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing…
Biosimilar SB2 May Work as Well as Infliximab for Rheumatoid Arthritis
In a 78-week study examining the interchangeability of infliximab with the biosimilar SB2, the treatments demonstrated long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis. Across all the study’s treatment groups, patients had similar treatment response rates, and the long-term clinical profile of SB2 was comparable with infliximab…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
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…
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…
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…
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…
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…
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