Biocon up 5% as USFDA issues CRL for proposed Biosimilar

The stock moved higher by 5.5% to Rs 363 on BSE in noon deal after the company said the USFDA has issued a Complete Response Letter (CRL) for proposed Biosimilar Pegfilgrastim.

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