 "Biocon's facility. Photo: Company's website")
Biocon moved higher by over 5% to Rs 363 on BSE in noon deals after the company said the US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) for proposed Biosimilar Pegfilgrastim.
“The US Food and Drug Administration have 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,” Biocon said in a BSE filing.
The CRL relates to the pending update of the BLA with certain CMC data from
“The US Food and Drug Administration have 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,” Biocon said in a BSE filing.
The CRL relates to the pending update of the BLA with certain CMC data from
