As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
Search results for: Remicade
Rheumatologists Concerned High Healthcare Costs May Encourage Patients to Forgo, Delay Treatment
While members of Congress debate healthcare legislation, rheumatologists say many of their patients struggle to afford everything from generic drugs to insurance copayments for physical therapy. “It’s a mess. The cost of prescriptions and the rationale for those rising costs in the U.S. right now—it’s just a mess,” says James R. O’Dell, MD, Stokes-Shackleford Professor of…
U.K. Competition Watchdog Accuses Merck of Obstructing Biosimilars
LONDON (Reuters)—Britain’s competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade (infliximab) that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) says it had provisionally found the U.S. company’s European unit, Merck Sharp & Dohme (MSD), had abused…
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…
Johnson & Johnson Discloses U.S. Probe Related to Arthritis Drugs
(Reuters) – Healthcare conglomerate Johnson & Johnson said on Monday the U.S. Department of Justice (DOJ) has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought two of its drugs. The U.S. healthcare company said its Janssen Biotech Inc. unit received a civil investigative demand from the DOJ…
Valeant Prices Psoriasis Treatment at $3,500 Per Month
(Reuters)—Canadian drug maker Valeant Pharmaceuticals International Inc. said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017. Brodalumab (Siliq) is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant says. Drugmakers are facing intense criticism from…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
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…
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…
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