USFDA seeks details of Biocon’s biosimilar cancer drug pegfilgrastim

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Biocon Ltd and Mylan NV's application for biosimilar pegfilgrastim seeking certain data before the product gets approval.

Biocon-Mylan biosimilar Pegfilgrastim is indicated for use in the treatment of cancer.

While the response process will take some time, Biocon said it does not expect the CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

"The US 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," Biocon said in a regulatory filing.

"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 bio-similarity, pharmacokinetic/ pharmacodynamic data, clinical data or immunogenicity," Biocon said.

"We do not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. We are committed to working with the agency to resolve the issues stated in the CRL expeditiously," the company added.

The US FDA issues complete response letters to communicate to a company that its application to market a drug will not be approved in its present form.

In the CRL, the regulator has sought certain data on chemistry, manufacturing and controls from facility requalification activities post recent plant modifications, Biocon said in an exchange filing on Tuesday.

''The CRL did not raise any questions on biosimilarity,  pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity. We do not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. We are committed to working with the agency to resolve the issues stated in the CRL expeditiously,'' Biocon said.

Shares of Biocon were trading 3.24 per cent higher at Rs355 apiece on BSE in morning trade today.