FDA Schedules ODAC Meeting for Rituximab Biosimilar

September 12, 2018 – The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for October 10, 2018, to discuss a biologics license application (BLA) for CT-P10, a proposed biosimilar to rituximab. The panel will discuss the benefits and risks of CT-P10 and issue nonbinding recommendations for the FDA to consider when making its approval decision. Celltrion, the company developing CT-P10 with Teva Pharmaceutical Industries, reported … (leggi tutto)