Genentech Expands Rituxan's Label Ahead of Potential Biosimilar Approval

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

In addition to previously being approved for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), the label for reference rituximab will now include information for follow-up treatment in adult patients with GPA and MPA who have achieved disease control with induction treatment.

“As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a statement.

The label update was based on data from the French Vasculitis Study Group which showed that rituximab plus glucocorticoids resulted in fewer major relapses by month 28 compared with azathioprine treatment. Further, the safety profile was consistent with that previously observed in this patient population. The approval makes the combination treatment the only FDA-approved therapy for these rare blood vessel disorders.

The expanded indications come soon after the FDA’s Oncologic Drug Advisory Committee (ODAC) held a meeting to discuss the Biologics License Application for a proposed rituximab biosimilar, CT-P10, developed by Celltrion and referencing Rituxan.

The committee heard data presented by various speakers that found that, although there were minor differences in clinically active compounds, the totality of the evidence suggested that the proposed biosimilar is highly similar to the reference product.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 committee members voted yes. The product will now be considered for licensure by the FDA, and, if approved, CT-P10 would be the first rituximab biosimilar available in the United States, providing competition to the previously unchallenged Rituxan. Celltrion, notably, is seeking approval for oncology indications only for its biosimilar due to the patent landscape for rituximab.