US FDA Issues Complete Response Letter For Proposed Biosimilar Pegfilgrastim

The U.S. 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. 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.

We do not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. We are committed to working with the agency to resolve the issues stated in the CRL expeditiously.