Sandoz Gains European Authorization for Pegfilgrastim Biosimilar, Ziextenzo

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

The biosimilar has gained authorization for the same indications as the reference drug: reducing the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy.

"Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity," Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a statement. "With the approval of Ziextenzo…we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."

Paul Cornes, MD, 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 in the United Kingdom added that “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.”

The authorization of Ziextenzo follows a September 2018 positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). The opinion was granted on the basis of data including positive phase 1 clinical data presented at the December 2017 San Antonio Breast Cancer Symposium. The molecule has also been studied in phase 3 clinical trials in patients undergoing chemotherapy. Sandoz had previously put the molecule forward for EMA review, but withdrew its application in October 2017 after CHMP raised concerns that Sandoz was not able to resolve in the timeframe permitted by the regulator.

The authorization of the biosimilar brings the number of EU-approved pegfilgrastim biosimilars to 4. A fifth pegfilgrastim product, Mylan’s Fulphila, is awaiting the European Commission’s decision on its own positive CHMP opinion, also rendered in September.