FDA Panel Backs Rituximab Biosimilar

October 10, 2018 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 recommending approval of the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody’s non-Hodgkin lymphoma indications. If the FDA agrees with the panel’s recommendations and approves CT-P10, the biosimilar would be approved to treat adult patients with CD20-positive follicular lymphoma combined with chemotherapy in the frontline setting, followed by … (leggi tutto)