FDA Rejects Novartis Biosimilar App for Amgen Neulasta

July 19, 2016

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