Amgen, Allergan join Rituxan biosimilar challenge with FDA filing

Amgen and Allergan have filed for approval of their biosimilar version of Roche’s CD20-targeting drug Rituxan with the FDA, vying to become the third copycat version of the blockbuster drug approved in the US. If approved, Amgen and Allergan’s biosimilar – called ABP 798 – will follow in the footsteps of Teva/Celltrion’s Truxima and Pfizer’s Ruxience, approved by the FDA in 2018 and earlier in 2019, respectively. A fourth potential rival developed by Novartis subsidiary Sandoz has been cleared in Europe but won’t be developed for the US market after the FDA requested more information on the drug last year. Rituxan (rituximab) – known as MabThera in some markets outside the US – is used to treat blood cancers including non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), as well as immunological diseases such as rheumatoid arthritis and various forms of vasculitis.