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HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.
Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.
“This latest study further reinforces Sandoz's strong commitment to increasing access to high-quality, affordable biopharmaceuticals and further expanding our biosimilars business,” Sandoz head of biopharmaceuticals and oncology injectables Ameet Mallik said. “Sandoz is looking forward to bringing the benefits of a high-quality, safe, effective and affordable epoetin alfa to patients, physicians and payers in the United States.”
Sandoz has marketed biosimilar epoetin alfa in the European Union for five years under the brand name Binocrit. The company said it also is enrolling patients and conducting other phase-2 and phase-3 trials of biosimilar versions of Roche's Rituxan (rituximab) and Amgen's Neupogen (filgrastim) and Neulasta (pegfilgrastim).
The Patient Protection and Affordable Care Act of 2010 included an amendment mandating a regulatory approval pathway for biosimilars, though the regulations have yet to be completed and put into place. Until that happens, companies looking to manufacture and market biosimilars for the United States market must still go through the same approval process that the Food and Drug Administration uses for brand-name biotech drugs.