The Oncologic Drugs Advisory Committee (ODAC) of FDA has unanimously recommended approval of subcutaneous (SC) rituximab for the treatment of patients with certain blood cancers. A final approval to this effect is expected by June 26, 2017 (Official Announcement). The approval of SC formulation certainly has its benefits such as, reduced drug delivery time – as opposed to an hour and half or more needed to administer IV formulation, the SC formulation could be delivered in less than 10 minutes. The significant reduction in administration time provides much needed relief to patients suffering from chronic conditions (iNHL, CLL, DLBCL). The SC formulation also improves the brand´s standing with payers and physicians. The SC formulation of Rituxan® is already approved by EMA and is marketed in EU since 2014 as MabThera SC®.
Roche will be looking forward to switching patients from IV to SC formulation upon approval, especially in light of upcoming potential biosimilar entries. Recently, a rituximab biosimilar Truxima® (Celltrion) was approved by EMA. A potential filing for approval of the same product in US is expected shortly. Rituxan® is a commercially successful product with annual sales of nearly $4 billion in US alone for Oncology indications. Roche will use this approval in the US to set up entry barriers for future biosimilars in US thereby safeguarding the revenue stream from Rituxan®.