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Search results for: biosimilar

Samsung Bioepis Humira Biosimilar Wins FDA Approval

Aakash Jagadeesh Babu and Bernard Orr  |  

(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…

British Columbia Will Be First Canadian Province to Switch Patients to Biosimilars

Allison Martell & Allison Lampert  |  

TORONTO/MONTREAL (Reuters)—The Canadian province of British Columbia said on May 28 that its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars, saving an estimated C$96.6 million ($71.9 million) over three years. The new policy from the province’s PharmaCare program targets Johnson & Johnson’s…

ACR Hill Visits Yield Key Bill Support; Plus Medicare, Biosimilar Wins

Angus Worthing, MD, FACP, FACR  |  

Greetings from Washington, D.C., where ACR leaders just held more than 100 meetings on Capitol Hill supporting reforms to step therapy and prior authorization, increased reimbursement for dual-energy X-ray absorptiometry (DXA), solutions to the rheumatology workforce shortage, and rheumatology-specific research at the Pentagon. We’re already hearing great news about our successes: Hours after our visit,…

IBD Patients Who Switch from Infliximab to Biosimilar See Mixed Results

Will Boggs MD  |  

NEW YORK (Reuters Health)—Patients with inflammatory bowel disease (IBD) can safely switch from infliximab to the biosimilar CT-P13, though they may face a higher risk of clinical relapse, researchers from Spain report. Recent studies have demonstrated the effectiveness and safety of infliximab biosimilars in patients with IBD, but there are limited data about the effectiveness…

Biosimilars: How Do They Affect Patient Care & Safety?

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CHICAGO—“We have got to get over this hump. We have got to try new stuff,” said Jacqueline M. Fritz, RN, MSN, CNS, to the audience gathered on the final day of the 2018 ACR/ARHP Annual Meeting, referring to the subject of biosimilars. Ms. Fritz, the owner and coordinator of education at the Medical Advancement Center…

Study Says 1 Biosimilar Switch Is OK; Jury Still Out on Multiple Switches

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AMSTERDAM—As more biosimilar drugs for rheumatic diseases make their way to market, evidence is growing that switching from the originator drug to a biosimilar tends to be effective, while the questions of switching back and forth, and switching multiple times using several different biosimilars, remain to be answered, an expert on the topic said at…