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Biocon intimates of CRL issued by USFDA

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For MYL-1401H, a proposed biosimilar pegfilgrastim

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 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.

does not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US.

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First Published: Tue, October 10 2017. 09:12 IST