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 reasons for the rejection were disclosed, nor were any timelines mentioned for a potential refiling