The US FDA 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 bisimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.
Biocon scrip of Rs. 5 each moved up by over Rs. 12 in the morning session on BSE to Rs. 356 today. Its market capitalisation worked out to Rs. 21,372 crore. The company said that the CRL will not impact the commercial launch timing of biosimilar pegfilgrastim in the US.
Us fda issues complete response letter, mylan, proposed biosimilar pegfilgrastim
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