For MYL-1401H, a proposed biosimilar pegfilgrastimBiocon announced that the USFDA has issued a Complete Response Letter (CRL) for Mylan'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.
The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.
Biocon does not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US.
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