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How Risky Is Pfizer’s Launch Of Its Remicade Biosimilar?

 
• By Brenda Sandburg

Following Sandoz’s Zarxio playbook, Pfizer plans to market Inflectra while patent litigation continues; February 2017 trial on cell culture media patent could answer question of potential damages.

Celltrion Inc. and partner Pfizer Inc. knocked out one of Janssen Biotech Inc.’s Remicade (infliximab) patents in district court and are betting they will win a ruling of non-infringement of a cell culture media patent. But even if they don’t prevail, they may rake in far more in revenues from an Inflectra biosimilar launch than would pay out in potential damages.

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

 
• By Derrick Gingery

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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• By Cathy Kelly

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Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

 
• By Dave Wallace

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