On December 2015 Sandoz, a Novartis company and global leader in biosimilars, reported results from the PROTECT 2 study which compared the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta* (Press release, Novartis, DEC 7, 2015, View Source [SID:1234508469]). The study met its primary endpoints – showing it to be both equivalent and non-inferior to the reference product. Data was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper), Orlando, Florida.

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Additional data from the study showed that there were no clinically meaningful differences between the proposed biosimilar pegfilgrastim and the reference product. Adverse events were similar and consistent with the known safety profile of pegfilgrastim, and no neutralizing anti-pegfilgrastim antibodies were detected.

"The positive data from the PROTECT 2 study is promising in that it will add to the body of evidence being developed on biosimilars. These findings could lead to another high-quality supportive care treatment option for physicians and oncology patients" said Kimberly Blackwell, MD, Professor of Medicine, Assistant Professor of Radiation Oncology, Duke University School of Medicine and primary investigator for the study.

Malte Peters, Head Biopharmaceutical Clinical Development, Sandoz said "The PROTECT 2 data is yet another demonstration of the substantial progress we are making with our biosimilar programs and the commitment we have made to improve patient access to these important medicines."

Sandoz has an unwavering commitment to increasing patient access to high-quality biosimilars. It is the pioneer and global market leader in biosimilars and was the first to launch biosimilars in the United States, Europe and Japan. Sandoz has a leading biosimilar pipeline with programs in various stages of development – the company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced two. On November 18, 2015, Sandoz announced that the FDA accepted its regulatory filing for the proposed biosimilar pegfilgrastim. As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its deep experience and capabilities in development, manufacturing and commercialization.

About PROTECT 2
The PROTECT 2 study was a global, randomized, double-blind trial involving 308 patients carried out in the United States, Latin America, Asia and Europe. The safety and immunogenicity of the proposed biosimilar was assessed for four weeks after the final study drug administration. The study analyzed the duration of severe neutropenia (DSN), which was also the primary endpoint.

About PROTECT 1
PROTECT 1 was a randomized, double-blind trial comparing the efficacy and safety of the proposed biosimilar pegfilgrastim (LA-EP2006) with reference pegfilgrastim in patients with breast cancer. PROTECT 1 data will be presented at San Antonio Breast Cancer Symposium, December 9, 2015 at 5 PM CST (SABCS Abstract #P1-10-01).