FDA panel to discuss Remicade biosimilar

FDA's Arthritis Advisory Committee will meet on March 17 to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). CT-P13, a humanized mAb against tumor necrosis factor (TNF) alpha, is marketed as Remsima outside the U.S.

Celltrion's application, which the company said is the first for a biosimilar mAb in the U.S., includes data from the Phase I PLANETAS trial to treat ankylosing spondylitis; the Phase III PLANETRA trial to treat rheumatoid arthritis (RA); and a bridging study that evaluated pharmacokinetic, pharmacodynamic and safety equivalency of CT-P13 and Remicade (see BioCentury Extra, Aug. 11, 2014). ...