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The Rules Of The Biosimilar Suffix

 
• By Derrick Gingery

FDA guidance outlines dos and don’ts for proposing a nonproprietary name suffix for a biosimilar.

As part of FDA’s proposed biosimilar naming convention, most biologics and biosimilars will have a suffix added to their product’s nonproprietary name that each sponsor must request.

The request would be made either during the IND phase or via a prior-approval labeling supplement if the product has been approved.

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More from United States

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

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UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

More from North America

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.