FDA approves Pfizer's biosimilar Ruxience

24 July 2019

In what has been a very active week for the US regulator in terms of approving new biosimilar medicines, the US Food and Drug Administration has approved a copy version of the leukemia drug sold by Roche (ROG: SIX) subsidiary Genentech as Rituxan (rituximab).

Pfizer (NYSE: PFE) late Tuesday announced the FDA has approved Ruxience (rituximab-pvvr) for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Roche’s MabThera/Rituximab (rituximab) generated first-quarter 2019 global sales 1.67 billion Swiss francs ($1.7 billion), down 1.3% year-on-year.

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