US FDA Issues CRL For Biocon and Mylan’s Pegfilgrastim Biosimilar

U.S. FDA News

As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US.  On October 10, Biocon reported that the FDA issued a Complete Response Letter (CRL).  According to Biocon, the CRL relates to “pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications” and is not expected “to impact the commercial launch timing of biosimilar pegfilgrastim in the US.”  Sandoz and Coherus have also received CRLs for pegfilgrastim in the US.

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