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Biosimilar Filgrastim Has Similar Safety and Efficacy as Neupogen in Phase III Study

Product investigated in breast cancer patients

New phase III data have demonstrated the similarity of investigational biosimilar filgrastim (Sandoz/Novartis) compared with the U.S.-licensed reference product Neupogen (filgrastim, Amgen) 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 had no effect on efficacy, safety, or immunogenicity.

The reference product, Neupogen, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

The PIONEER trial was designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to the mean duration of severe neutropenia after one cycle of chemotherapy. The randomized, double-blind, non-inferiority trial involved 218 breast cancer patients.

In July 2014, the FDA accepted a new drug application for biosimilar filgrastim. Results from the PIONEER study supported this filing.

“Biosimilars can play an important role in broadening access to high-quality biologics in the United States,” said Kimberly Blackwell, MD, Professor of Medicine at the Duke University School of Medicine. “I’m also optimistic that the savings generated through the use of biosimilars can be used to fund other unmet medical needs.”

Biosimilar filgrastim is currently marketed in more than 40 countries outside the U.S. under the brand name Zarzio (Sandoz).

Sources: Sandoz; December 8, 2014; and Novartis; July 24, 2014.


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