Sandoz initiates two more Phase III biosimilar trials

Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX), says that it has initiated two milestone Phase III clinical trials - one for biosimilar filgrastim (Amgen's Neupogen) in the US market, the other for its global pegfilgrastim development program (Amgen's Neulasta).

"Sandoz is already the clear global leader in biosimilars overall and in each of our three marketed products, with approximately 50% total segment share in the highly regulated markets of North America, Europe, Japan and Australia," said Sandoz's global head, Jeff George, adding: "These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline."

The filgrastim study is to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen in breast cancer patients eligible for myelosuppressive chemotherapy treatment. It is expected to support extension of commercialization to the USA, the largest global market for biologics. Sandoz's filgrastim biosimilar is already marketed under the brand name Zarzio in more than 30 countries outside the USA.