Sandoz says Phase III trials show proposed biosimilar pegfilgrastim has similar safety and efficacy as reference product

Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis (NOVN: VX) said late stage trials to compare the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta (pegfilgrastim), met its primary endpoints.

Additional data from the study showed that there were no clinically meaningful differences between the proposed biosimilar pegfilgrastim and the reference product.

Dr Kimberly Blackwell, primary investigator for the study, said: "The positive data from the Protect II 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."