On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.
With the new indication, Amgen’s Riabni® is now approved for all indications of Genentech/Biogen’s Rituxan®, while Celltrion’s Truxima® is approved for all of Rituxan®’s non-paediatric indications. Pfizer’s Ruxience® is the only biosimilar without full adult coverage, missing both chronic lymphocytic leukemia and rheumatoid arthritis.
Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. Truxima®, Riabni® and Ruxience® are currently the only three rituximab biosimilars approved in the US market, with Dr Reddy’s rituximab biosimilar being knocked back by the FDA in April 2024.