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November 29, 2018Truxima, First Rituxan Biosimilar, Approved
November 28, 2018 – The U.S. FDA has approved Truxima® (rituximab-abbs), manufactured by Celltrion, to treat certain adult patients who have non-Hodgkin lymphoma (NHL). This is the first biosimilar for Genentech’s Rituxan® (rituximab) to receive FDA approval.
Although biosimilars must be highly similar to the original reference product in composition, efficacy, and safety, they are not automatically interchangeable. Truxima's indications are more limited than those approved for Rituxan. Specifically, Truxima is approved for treatment of the following:
- Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
According to a statement, Celltrion intentionally sought FDA approval for only three NHL indications due to "the patent and exclusivity landscape at this time."Rituxan, in comparison, holds four NHL indications, and is also approved to treat chronic lymphocytic leukemia (CLL) and a number of inflammatory conditions. Both Truxima and Rituxan carry black box warnings for several potentially fatal risks:
- Fatal infusion reactions within 24 hours of infusion, approximately 80% of which occur after the first infusion;
- Severe, potentially fatal mucocutaneous reactions (reactions that affect the skin and mucous membranes);
- Hepatitis B virus (HBV) reactivation that may result in fulminant hepatitis (a syndrome marked by acute liver atrophy and tissue death), liver failure, and death; and
- Progressive multifocal leukoencephalopathy (PML), a serious and potentially fatal condition that affects the brain.
Truxima's recommended dose is 375mg/m 2 of body surface area. The product will be available in single dose vials containing 100mg/10mL (10mg/mL) or 500mg/50mL (10mg/mL) solution. The company has not yet announced pricing or launch plans.
