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Biocon gets complete response letter from US drug authority for anti-cancer drug (.hindu)

Biotechnology firm Biocon on Tuesday said the United States health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, indicated for use in cancer treatment.

The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the U.S. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

“The U.S. Food and Drug Administration [USFDA] has issued a complete response letter for Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim,” Biocon said in a regulatory filing.

It said:

“The CRL relates to the pending update of the BLA with certain CMC [Chemistry and Manufacturing Control ] 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.

“We do not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the U.S. We are committed to working with the agency to resolve the issues stated in the CRL expeditiously.”

Shares of Biocon were trading 3.24% higher at ₹355 apiece on BSE (Bombay Stock Exchange) in morning trade on Tuesday.

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