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As per Biocon, the US health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, which is to be used in treatment for cancer.
This product is a part of the biosimilars portfolio being jointly developed by Biocon and Mylan .
Biocon in a regulatory filing stated,”The US Food and Drug Administration has issued a complete response letter (CRL) for Mylan’s Biologics License Application(BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim.”
Further it said that, it is not expecting the CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US.
