Sandoz highlights positive performance of new breast cancer biosimilar

Sandoz has announced positive phase III trial data for biosimilar filgrastim, its investigational treatment based on Amgen's branded product Neupogen.

Results from the phase III Pioneer study showed that Sandoz's biosimilar offered similar safety and efficacy to Neupogen in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. 

Moreover, repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity, thus proving the new version's non-inferiority.

The company has already applied for US regulatory approval of the new biosimilar, underlining its position as the global market segment leader.

Dr Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said: "The data from this important study also reinforces the results we have seen in earlier stages of development, including multiple phase I, pre-clinical and analytical studies."

Sandoz currently accounts for more than a 50 percent volume share of all biosimilars approved in North America, Europe, Japan and Australia. Biosimilar sales growth helped the company achieve strong momentum in the first nine months of 2014.