Biotechnology firm Biocon today said the US health regulator has issued complete response letter (CRL) for Mylan's application for proposed biosimilar Pegfilgrastim, indicated for use in treatment of cancer.
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 CRL for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim", Biocon spokesperson said in a statement.
The USFDA issues a CRL to convey to a company that its initial review of an application is complete and it cannot approve the application in its present form.
"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 biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity," the statement added.
The company said it does not expect the CRL to impact the timing of the launch of biosimilar Pegfilgrastim in the US market.
"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 spokesperson said.
The proposed biosimilar is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the companies had earlier said.
Shares of Biocon were trading at Rs 357.65 per scrip in the afternoon trade on BSE, up four per cent from its previous close.
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