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Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles

 
• By Bridget Silverman

First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.

Drug Review Profile regular column

FDA's biosimilars pathway has encouraged a large and active pipeline of potential products, but translating statutory directives into practical processes has not always gone smoothly.

FDA has only approved five products under the pathway, which was signed into law in 2010. The Biologics Price Competition...

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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

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

 
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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
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US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

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