October 10, 2017 / 5:39 AM / 8 months ago

BUZZ-India's Biocon gains; co says FDA letter not to hit US drug launch

** Shares in Biocon Ltd rise as much as 4.9 pct to 361.20 rupees, their highest since Sept 22

** Biocon says complete response letter (CRL) issued by U.S. FDA for proposed biosimilar Pegfilgrastim will not impact its commercial launch timing in the United States

** Issuance of CRL indicates the regulator is not prepared to approve the drug at this time

** Co says CRL did not raise any questions on biosimilarity, clinical data or immunogenicity, but relates to certain manufacturing and testing data from facility after recent plant modifications

** Biocon adds it is working to resolve the issues raised expeditiously

** The biosimilar, jointly developed with Mylan, is aimed at reducing the risk of infection in patients undergoing chemotherapy

** Biocon posts biggest intraday pct gain since Sept 8; up 8.7 pct this year as of Monday’s close

** About 3 mln shares change hands versus 30-day avg volume of 1.7 mln

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