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Sandoz starts two late-stage biosimilar trials

Trials of filgrastim, pegfilgrastim designed to support drugs' U.S. approval

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

The generics arm of Swiss drug maker Novartis announced the start of phase-3 clinical trials of filgrastim and pegfilgrastim, respectively biosimilar versions of Amgen's Neupogen and Neulasta. Both drugs are used to prevent neutropenia, a side effect of some chemotherapy treatments that results in low counts of white blood cells, known as neutrophils, and can lead to dangerous infections.

"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," Sandoz global head Jeff George said. "These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline."

Sandoz already markets filgrastim under the brand name Zarzio in more than 30 countries outside the United States, where a large healthcare reform bill included the creation of a regulatory approval pathway for biosimilars. In addition, it markets the growth disorder drug Omnitrope (somatropin), a biosimilar of Pfizer's Genotropin, in the United States under a special approval pathway that the Food and Drug Administration created in 2006.


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