Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.
Search results for: biosimilar
FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease
The FDA has approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin 1 receptor antagonist. The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.
Patients Demonstrated Good Medication Adherence While Taking Biosimilar Treatment
Researchers found half of patients taking the biosimilar infliximab-dyyb (Inflectra) remained highly adherent to medication use after 12 months.
UHC Updates Rituximab Policy to Require Use of Biosimilars
As of Oct. 1, UnitedHealthcare (UHC) requires that patients fail to respond to both FDA-approved rituximab biosimilars prior to receiving approval for rituximab. Exception: Rituximab-pvvr (Ruxience) is not FDA approved for rheumatoid arthritis.
Biosimilar Prescribing Habits in the VA & Academic Settings
In a new study, Baker et al. examined reference product and biosimilar orders, comparing data from a Veterans Affairs Medical Center (VAMC) to those from an academic medical center…
Biosimilars Are Slowly Climbing Toward Acceptance in Rheumatology
As useful stand-ins for biologics targeting a range of inflammatory diseases, biosimilars have made significant inroads across Europe as less expensive alternatives. Denmark, for example, realized a cost savings of 64% after instituting a mandatory national switch from the originator infliximab to its biosimilar counterpart. In the U.S., however, a considerably smaller fraction of rheumatologists…
U.S. Insurers Often Limit Biosimilar Coverage
(Reuters Health)—U.S. commercial health plans only covered biosimilar treatments as preferred products in 14% of coverage decisions last year, according to an analysis of publicly available data on coverage decisions.1 Researchers examined records from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database, which has information on coverage decisions made by 17 of…
EU Approves Remsima SC, a Biosimilar to Infliximab
Subcutaneous CT-P13 (Remsima SC), biosimilar to infliximab, will soon be available in the E.U. to treat adults with rheumatoid arthritis…
FDA Approves Amgen’s Infliximab Biosimilar Treatment
(Reuters)—The U.S. Food and Drug Administration on Friday approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade (infliximab), according to the regulator’s website. The biosimilar, Avsola (infliximab-axxq), has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders. The label for the…
FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
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