FDA Issues Complete Response Letter for Pegfilgrastim Biosimilar

October 10, 2017 – Biocon has announced that the FDA has issued a complete response letter (CRL) for Mylan’s biologics License Application (BLA) for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim. The company issued a statement reporting that the CRL relates to a pending update of the BLA to include information regarding facility requalification activities taken since the addition of recent plant modifications. “The CRL did not raise any questions on biosimilarity … (leggi tutto)