Date: 2014-12-08
Type of information: Results
phase: 3
Announcement: results
Company: Sandoz (Switzerland)
Product: filgrastim biosimilar (Neupogen®)
Action
mechanism: biosimilar/protein
Disease: breast cancer patients eligible for myelosuppressive chemotherapy treatment
Therapeutic area: Cancer - Oncology
Country: Czech Republic, Hungary, Latvia, Russian Federation, Slovakia, Ukraine
Trial
details: The filgrastim study is to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. It is expected to support extension of commercialization to the US, the largest global market for biologics. Sandoz's filgrastim biosimilar is already marketed under the brand name Zarzio® in more than 30 countries outside the United States.
Latest
news: * On December 8, 2014, Sandoz, a Novartis company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen’s Neupogen® (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity.The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy. On July 24, Sandoz announced that the FDA accepted its application for filgrastim, making Sandoz the first company to have a filing accepted under the new US biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
