“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 facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity, it added.
The company said it does not expect the 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”, it added.
At 02:12 PM; the stock was up 5% at Rs 362 on the BSE, as compared to 0.23% rise in the S&P BSE Sensex. The trading volumes on the counter jumped nearly five-fold with a combined 5.4 million shares changed hands on the BSE and NSE.