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

Sandoz's late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved.

Commenting on this milestone, Richard Francis, Division Head and CEO Sandoz said: "Securing five major regulatory file acceptances in 5 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.

"Sandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment" said Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. "If approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors" McCamish continued.