Sandoz' Biosimilar A Suitable Alternative To Amgen's Neupogen
Novartis company Sandoz reported late-stage data showing that its investigational biosimilar filgrastim has comparable safety and efficacy to its reference product Neupogen (filgrastim) by rival company Amgen.
Filgrastim is a biosimilar of Neupogen indicated for the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The company’s Biologics License Application (BLA) for filgrastim was accepted for review in July by the U.S. Food and Drug Administration (FDA).
The pivotal, randomized, double-blind Phase 3 study PIONEER investigated the safety and efficacy of Sandoz’s filgrastim biosimilar and Amgen’s reference product in connection to mean duration of severe neutropenia following Cycle 1 chemotherapy in 218 patients with breast cancer undergoing neoadjuvant myelosuppressive chemotherapy. Results showed that repeated switching at each treatment cycle between the biosimilar product and the reference filgrastim resulted in no significant difference in safety, efficacy, or immunogenicity.
Dr. Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz, said, “We are pleased by these clinical study results as they confirm the similarity of our investigational biosimilar filgrastim compared to the reference product in terms of safety and efficacy. The data from this important study also reinforces the results we have seen in earlier stages of development, including multiple Phase 1, pre-clinical, and analytical studies.” Dr. McCamish added that the company is anticipating the launch of its biosimilar product in the U.S.
The results of the late-stage PIONEER study were published online as part of the company’s presentation at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition.
Last week, Sandoz lost its bid to protect its investigational version of Amgen’s psoriasis and arthritis drug Enbrel from infringing two of its rival’s patents. While the ruling of the highest U.S. patent appeals court does not stop Sandoz from developing its Enbrel biosimilar, it does not bestow protection to the company against potential patent lawsuits.