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.
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...
Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.
In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.
Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.
