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Biocon receives CRL from USFDA for anti-cancer drug

Shares of Biocon were trading 3.24 per cent higher at Rs 355 apiece on BSE in morning trade

Press Trust of India  |  New Delhi 

Biocon's facility. Photo: Company's website
Biocon's facility. Photo: Company's website

Biotechnology firm on Tuesday said the US health regulator has issued (CRL) for proposed biosimilar Pegfilgrastim, indicated for use in the treatment of

The company, however said it does not expect this 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 and Mylan.


"The U.S. Food and Administration has issued a (CRL) for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim," said in a regulatory filing.

It further said: "The relates to the pending update of the BLA with certain data from facility requalification activities post recent plant modifications. The did not raise any questions on biosimilarity, pharmacokinetic/ pharmacodynamic data, clinical data or immunogenicity".

"We do not expect this 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 expeditiously," the company added.

Shares of were trading 3.24 per cent higher at Rs 355 apiece on BSE in morning trade today.

First Published: Tue, October 10 2017. 13:46 IST
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