Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

Novartis International AG / Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Sandoz' late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved
• Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, demonstrates that the proposed biosimilar is highly similar to the reference product.
• Sandoz is the European market leader in both the daily G-CSF class and for biosimilar filgrastim.

Holzkirchen, 11 February, 2016 - Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta^®* (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.

Commenting on today's milestone, Richard Francis, Division Head and CEO Sandoz 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."

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The incidence of febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.[1]