Phase III data shows Sandoz’ investigational biosimilar filgrastim has similar safety and efficacy as Amgen’s NEUPOGEN®

Sandoz, a Novartis company, announced today 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). The Phase III PIONEER study results supported this filing. “Biosimilars can play an important role in broadening access to high-quality biologics in the United States,” said Prof. Kimberly Blackwell, MD, Professor of Medicine, Assistant Professor of Radiation Oncology, 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.”

“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 Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “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. We look forward to making this product available to patients and healthcare providers in the United States.”

Sandoz is the global market segment leader with over 50 percent volume share of all biosimilars approved in North America, Europe, Japan and Australia. Sandoz currently markets three biosimilars outside the US; each of which occupies the #1 biosimilar position in its respective category. Sandoz biosimilars are sold in over 60 countries and have generated over 170 million patient-exposure days in experience. Sandoz also has a robust pipeline with six molecules in Phase III clinical trials/registration – more than any other company in the industry.