European Commission grants marketing authorisation for Sandoz biosimilar Ziextenzo ® (pegfilgrastim).
Sandoz, a Novartis division, has announced that the European Commission (EC) has granted marketing authorisation for biosimilar Ziextenzo® (pegfilgrastim).
Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes. These indications match those of the reference medicine.
This approval was based on comprehensive analytical, preclinical and clinical data. In these studies, Ziextenzo matched the reference medicine in terms of safety, efficacy and quality. Pegfilgrastim, the active substance in Ziextenzo, is a long-acting form of filgrastim, which stimulates the production of white blood cells.
“Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity,” said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. “With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer.”
“Pegfilgrastim biosimilars, such as Ziextenzo, mark a true advancement for people with cancer. These medicines help deliver optimized long-acting dosing and patient convenience while creating savings for our hard-pressed health systems,” said Dr. Paul Cornes, oncologist and member of the Continuing Medical Education program of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, United Kingdom.
Sandoz has had eight biosimilars approved in the EU, including five in last 18 months.