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EU Data Helps Sandoz’s U.S. Clinical Program For Filgrastim

 
• By Derrick Gingery

Because FDA agreed data comparing Sandoz’s filgrastim to EU-approved Neupogen could serve as bridge for comparisons to U.S.-approved Neupogen, firm only needed two additional studies for its biosimilar application.

Sandoz Inc. illustrated the power of bridging data with its filgrastim biosimilar application. The company submitted eight studies in its data package, but only a fraction compared its filgrastim to its U.S.-approved reference product, Amgen Inc.’s Neupogen.

Analytical characterization and other data convinced FDA that a scientific bridge had been established to show studies comparing its filgrastim...

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