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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 to the version of Neupogen approved in the European Union...

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More from United States

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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