CHICAGO—ACR leaders described a series of looming legislative and regulatory threats to rheumatologists and their patients—including the proposed collapsing of evaluation and management (E/M) coding and potential changes to step therapy rules—and urged everyone in the field to make their voices heard to quash the proposals. They also recounted recent victories in the policy realm…
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
CHICAGO—Amid what she called a “dizzying array of choices” for rheumatoid arthritis (RA)—from anti-TNF and anti-IL6-receptor therapies to B cell depletion to new biosimilar options—disease treatment should still revolve around several basic concepts, an expert said at the ACR State-of-the-Art Clinical Symposium in April. Joan Bathon, MD, chief of rheumatology at Columbia University in New…
Greetings, Advocates! In my last update, I described the great news from February’s budget agreement that fixed Medicare’s payment adjustments so MIPS penalties would not include Part B drug costs, ensuring stabilization of the Medicare Part B drug system, among other successes. (Read the ACR’s press release on this topic.) I also described the Trump administration’s…
LONDON (Reuters)—Cut-price copies of expensive biotech drugs promise to slash the cost of treating serious diseases, including cancer, in rich and poor countries alike -but uneven regulation has created a lopsided market. Now the World Health Organization (WHO) is stepping in to assess the quality of such so-called biosimilars, offering a global stamp of approval…
(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…
Although six biosimilar agents have now been approved by the U.S. Food & Drug Administration for use in rheumatology, scientific, clinical, economic and prescribing questions about the use of biosimilars abound. In fact, at the 2017 ACR/ARHP Annual Meeting in San Diego, Joseph Huffstutter, MD, a rheumatologist in private practice in Chattanooga, Tenn., said that…
The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
NEW YORK (Reuters Health)—The biosimilar LBEC0101 is equivalent to etanercept (Enbrel) in treating patients with rheumatoid arthritis (RA) who respond inadequately to methotrexate, according to researchers from Korea and Japan. As Dr. Yeong-Wook Song tells Reuters Health by email, “LBEC0101 is comparable in efficacy, safety and immunogenicity profile to Enbrel.” The findings, he adds, could…
SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…