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Novel Biologics In US Might Not Start Getting Suffixes Until August

 
• By Michael Cipriano

FDA has cleared four novel biologics without a suffix despite finalizing nonproprietary naming guidance; the agency requests sponsors submit proposed suffixes at the time a BLA is submitted.

the word suffix on cubes

In January, the US FDA finalized a guidance that changes the way biologic products should be named. So far, the agency hasn't been following it.

Over the course of a week last month, FDA approved three novel biologics – Genentech Inc.'s multiple sclerosis treatment Ocrevus (ocrelizumab), Sanofi and Regeneron Pharmaceuticals Inc.'s atopic dermatitis treatment Dupixent (dupilumab), and Pfizer Inc. and EMD Serono Inc

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New EU Filings

 
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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

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