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,…
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients
The FDA has approved Truxima (rituximab-abbs), which is biosimilar to Rituxan (rituximab), for treating adults with CD20-positive, B-cell non-Hodgkin’s lymphoma…
ACR Leaders Discuss E/M Coding Changes, Step Therapy & More
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…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
4 Rheumatoid Arthritis Therapy Principles, & New Drug Info
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…
ACR/ARHP Visits the Hill; Drug Pricing ‘Blueprint’ Revealed
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…
Gap in Regulating Biotech Drug Copies Prompts WHO to Step In
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…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(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,…
The Science Behind Biosimilars
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…
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