EMA Accepts Sandoz’s Application for Neulesta Biosimilar

The European Medicines Agency has accepted Sandoz’s MAA for its biosimilar of Amgen’s Neulesta to help the body make white blood cells after receiving cancer medications.

The submission — which is seeking the same indication as Neulesta — is the latest in Sandoz’s biosimilar spree, marking the company’s fifth of 10 that it plans to make by 2017. Sandoz, a unit of Novartis, previously submitted its application for its Neulesta knockoff to the FDA in November.

Data from three pivotal clinical studies of the candidate are expected to satisfy the EU’s requirements for high similarity to the reference product, Sandoz says.

Sandoz’s first biosimilar product was Zarxio, which launched in September and referenced Amgen’s chemotherapy drug Neupogen.