Study Suggests CPT-13 Comparable to Infliximab at Lower Cost in Patients With IBDJanuary 18th 2020
The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.
Faster Drug Approvals, Weaker Data? Study Raises Concerns About FDA ProcessJanuary 14th 2020
An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.
ICER Releases Final Report on JAK Inhibitors for Rheumatoid ArthritisJanuary 13th 2020
The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.