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Biocon-Mylan co-developed Pegfilgrastim gets US FDA CRL


The U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for Mylan’s Biologics License Application (BLA) for MYL-1401H

By Team ABLE

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.

Biocon has stated in the press release that the company does not expect the CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. The company promises to stay committed to working with the agency to resolve the issues stated in the CRL expeditiously.