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Agnes Shanley is senior editor of Pharmaceutical Technology.
Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.
Sandoz announced on Dec. 8, 2014 that its PIONEER Phase III study demonstrated the similarity of its investigational biosimilar, filgrastim, with Amgen’s Neupogen. The drug is designed to prevent severe neutropenia in breast cancer patients who are receiving chemotherapy. Studies reportedly showed that repeated switching between the investigational biosimilar and the original drug had no impact on efficacy, safety or immunogenicity.
The study was a randomized, double-blind, four-group trial conducted at 27 centers, Nasdaq reported, and evaluated 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
FDA accepted Sandoz’s application for filgrastim on July 24, marking the first time that a filing was accepted under the US Biologics Price Competition and Innovation Act of 2009.
"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," said Dr. Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz. "The data from this important study also reinforce the results we have seen in earlier stages of development including multiple Phase I, pre-clinical and analytical studies. We look forward to making this product available to patients and healthcare providers in the United States."
Sandoz currently markets three biosimilars outside the U.S.and sells biosimilars in over 60 countries.