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 (Neulasta).
In June, the agency issued a CRL for a BLA for CHS-1701, a pegfilgrastim biosimilar from Coherus BioSciences, requesting a reanalysis of a subset of subject samples with a revised immunogenicity assay and additional information on the manufacturing process.
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