Novartis Gives Up On Rituxan Biosimilar For US Market

Thwarted by the FDA, Novartis sees better opportunities for other biosimilars in its portfolio and has decided not to pursue a refiling for its version of Roche's blockbuster Rituxan. However CEO Vas Narasimhan told Scrip that the US remains very much a focus of the group's biosimilars strategy.

Boxing — Novartis calls it quits on Rituxan biosimilar • Source: Shutterstock

Novartis AG has thrown in the towel on getting US approval for a biosimilar of Roche's lymphoma, leukemia and rheumatoid arthritis drug Rituxan (rituximab), after the FDA asked for more information on the company’s version of the drug, which is approved already in Europe and elsewhere.

In May, Novartis generics unit Sandoz received a complete response letter from the FDA for its Rituxan biosimilar and no...