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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 and Innovation Act provided an abbreviated approval pathway for biological...

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

 
• By Sue Sutter

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

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

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.

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

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.