On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for “frequently relapsing or steroid-dependent nephrotic syndrome” in childhood (IV injection, 100mg and 500mg) that has not yet become intractable.
Rituxan® was approved in Japan in November 2024 for chronic idiopathic thrombocytopenic purpura (ITP) in children. Prior to this, Rituxan® had only been approved in Japan for chronic ITP in adults.
Rituximab was one of the first mAbs to become “biosimilar”. Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).