Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear
Executive Summary
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.
You may also be interested in...
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.
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.
Epogen Biosimilar Jury Verdict May Ignite New 'Safe Harbor' Battle
Amgen awarded $70m in damages after jury finds certain batches of Hospira's Epogen biosimilar infringed a manufacturing process patent; case offers 'juicy legal issue' for Federal Circuit to address.