Pegfilgrastim greenlight marks eighth biosimilar approval in Europe for Sandoz
pharmafile | November 27, 2018 | News story | Manufacturing and Production, Sales and Marketing | Amgen, Neulasta, Sanofi, Ziextenzo, biosimilars, pegfilgrastim, pharma
The European Commission has chosen to grant marketing authorisation to Ziextenzo, Sandoz’s biosimilar version of pegfilgrastim, better known as Amgen’s Neulasta, the company has announced.
Specifically, the therapy is approved 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.
The approval marks the eighth biosimilar approval in Europe for Sandoz and comes just a day after the EC announced the approval of Mundipharma’s own Neulasta biosimilar. The decision was made on the back of data supporting Ziextenzo’s non-inferiority to its reference product in terms of safety and efficacy.
“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,” remarked Dr Paul Cornes, oncologist and member of the Continuing Medical Education programme of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, UK.
Stefan Hendriks, Global Head of Biopharmaceuticals at Sandoz, also commented: “Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity. 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.”
Matt Fellows
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