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GC Pharma/Biocon Eye Low Price Strategy As Biosimilar Insulin Glargine Approved In Korea

 
• By Jung Won Shin

GC Pharma/Biocon are set to adopt a low price strategy for their biosimilar insulin glargine, which has just received regulatory approval in South Korea, to better compete with rival products.

Approve

South Korea's Ministry of Food and Drug Safety has granted the green light to Biocon Ltd.'s Glarzia, a biosimilar version of

Sanofi's Lantus (insulin glargine), paving the way for the product to become the second Lantus

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

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.

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