FDA Issues CRL Seeking More Data on Biocon/Mylan Neulasta Biosimilar

Biocon has acknowledged that the FDA has held off approving its application with Mylan to market a biosimilar version of Amgen’s Neulasta ® (pegfilgrastim) pending submission of additional data.Biocon said the companies have received a Complete Response Letter (CRL) asking them to update their Biologics License Application (BLA) for MYL-1401H, a near-copy of pegfilgrastim. The agency is seeking additional chemistry, manufacturing, and controls data from facility requalification activit