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Apotex Moves To Block Coherus' Neulasta Biosimilar; Asks FDA To Require Patient Studies

 
• By Brenda Sandburg

Apotex argues that biosimilar studies in healthy volunteers are not sufficient to show clinically meaningful differences with the reference product; Coherus says it believes its application is scientifically sound.

Three weeks before FDA is to take action on Coherus BioSciences Inc.'s Neulasta (pegfilgrastim) biosimilar application, Apotex Inc. has asked the agency to require all pegfilgrastim sponsors to conduct studies in the intended patient population, not just in healthy volunteers.

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More from Biosimilars & Generics

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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

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