EMA accepts Sandoz MAA for biosimilar

Global biosimilars leader Sandoz has had its Marketing Authorization Application for its biosimilar to Amgen's (Nasdaq: AMGN) EU-licensed Neulasta (pegfilgrastim) accepted by the European Medicines Agency.

Neulasta is a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF) and Sandoz, a Novartis (NOVN: VX) company, is seeking approval for the same indication as the reference product.

Richard Francis, Division Head and chief executive said: "Securing five major regulatory file acceptances in five months demonstrates substantial progress on our long-term biosimilars investment strategy. Further advancing our biosimilars pipeline is an important priority for us this year and we'll continue to invest significantly in bringing our pipeline to patients."