Biocon: Mylan gets complete response letter from USFDA

Biocon: Mylan gets complete response letter from USFDA The US Food and Drug Administration has issued a Complete Response Letter (CRL) for Mylan#39;s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.