The U.S. FDA has declined to approve Novartis' application for a biosimilar copy of Amgen's blockbuster, Neulasta.
Novartis noted briefly in its Q2 report: "Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta®). We are working with the agency to address remaining questions."
Approved in 2002, Neulasta is used to help reduce the chance of infection due to a low white blood cell count, in people with non-myeloid cancer, who receive chemotherapy that can cause fever and low blood cell count.
Sandoz did not provide further details regarding the complete response letter.
Read the Reuters brief