During the 2017 ACR/ARHP Annual Meeting, advances in biosimilar treatments were abuzz. However, many speakers noted that the presence of biosimilars on the market has not yet resulted in greater access to treatment and lower drug pricing in the U.S…
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…
Pfizer’s Second Biosimilar of J&J’s Remicade Wins U.S. FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed…
Sen. Lisa Murkowski Addresses Rheumatologists During ACR/ARHP Annual Meeting, Tax Reform & More
Greetings, advocates! This month’s Washington update covers how Congress’s tax proposals affect rheumatology, the ACR’s plan to fight Medicare’s adjustments to Part B drug costs in MIPS, the good news of Medicare’s new individualized biosimilar reimbursement, advances in the rheumatology-specific Alternative Payment Model and developments in Congress’s awareness about the perilous pharmacy benefit manager system….
Biosimilars Great Debate: To Switch or Not?
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…
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…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?
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…
CMS Implements Part B Modifiers for Biosimilars
With the advent of biosimilars to the marketplace, the Centers for Medicare and Medicaid Services (CMS) now requires modifiers to identify the manufacturer of a biosimilar/biological product on Part B claims. Modifiers were put in place to provide the CMS with the necessary data needed to track claims payments, as well as the ability to…
2 Biosimilars Make Their Way Toward the European Market
Two biosimilar treatments, Rixathon and Imraldi, are moving closer to market release in Europe for the treatment of rheumatic and other diseases…
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