A review of regulatory and drug development status updates.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
The phase 3 BE COMPLETE study included 400 adults with active psoriatic arthritis who were inadequate responders or intolerant to anti-TNF-α therapy.
The ongoing phase 3 BE MOBILE 1 study compared the efficacy and safety of bimekizumab to placebo in adults with active nr-axSpA.
The approval was based on data from the 2-year phase 3 JUNIPERA study that evaluated secukinumab in pediatric patients aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Panel of serum protein biomarkers identified and evaluated for potential use in diagnostic testing for early-onset psoriatic arthritis