10 October 2017 - The U.S. FDA has issued a complete response letter for Mylan´s biologics license application for MYL-1401H, a proposed biosimilar pegfilgrastim.
This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.
The letter relates to the pending update of the BLA with certain CMC data from facility re-qualification activities post recent plant modifications. The letter did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.