US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals
Agency is meeting its review timelines for biosimilar applications but handing our more complete response letters than first-cycle approvals; sponsors have publicly disclosed 24 original biosimilar application submissions to the agency since the review program began in fiscal year 2013, with 10 product approvals to date and at least 13 CRLs, according to the Pink Sheet's biosimilars report card.
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Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear
First biosimilar of Epogen/Procrit might launch this year, but timing of market entry will depend on many factors, including ongoing patent litigation with Amgen in Delaware federal court.
GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?
Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site.
US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards
Updated interchangeability guidance is one of several 'incremental reforms' agency is working on that could ease development burden for biosimilars, Commissioner Scott Gottlieb says.