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Neupogen Claim’s Orphan Protection May Keep Zarxio At Bay

 
• By Sue Sutter

FDA approval of Amgen’s granulocyte colony-stimulating factor for treatment of acute radiation syndrome carries seven years of orphan product exclusivity, which may keep the indication off the label of Sandoz’s biosimilar.

Orphan drug protection attached to a new claim for Amgen Inc.’s Neupogen (filgrastim) may preclude Sandoz Inc. from adding the same indication to labeling for its biosimilar Zarxio (filgrastim-sndz) in the near future.

On March 30, FDA approved Neupogen, a granulocyte colony-stimulating factor, for treatment of patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, H-ARS).

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More from United States

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

More from North America

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.