The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
Etanercept Biosimilar Is Effective, Well-Tolerated for Rheumatoid Arthritis
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…
Health Plans Enact Coverage Policies for Remicade & Infliximab Biosimilars
Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing…
U.S. Appeals Court Invalidates J&J Patent on Remicade
(Reuters)—A U.S. appeals court on Tuesday upheld a ruling that invalidated a crucial Johnson & Johnson patent on its blockbuster rheumatoid arthritis drug, Remicade (infliximab), limiting J&J’s ability to seek damages from Pfizer Inc. over its launch of a lower-cost version of the drug. The U.S. Circuit Court of Appeals for the Federal Circuit affirmed…
EU Approves Certolizumab Pegol for Pregnant & Nursing Patients
In the EU, certolizumab pegol has been approved for use in pregnant and nursing women with chronic rheumatic disease…
Should Patients with Rheumatic Disease Switch from Biologic to Biosimilar?
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…
Biosimilars: Still Waiting for Promise to Materialize
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…
Bimekizumab Improves Joint & Skin Symptoms in PsA Patients
Preliminary results from an ongoing study show that bimekizumab improves joint and skin symptoms in patients with psoriatic arthritis…
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…
Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…
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