Biocon withdraws MAAs for trastuzumab and pegfilgrastim biosimilars
Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said it will withdraw at EMA's request MAAs for its biosimilars of trastuzumab and pegfilgrastim due to the need for re-inspection of Biocon’s Bangalore drug substance and drug product sites. Biocon said that while the original inspection found no critical observations, a second inspection is required to verify the company has implemented the corrective and preventive actions (CAPAs) as recommended in the original report. Biocon did not disclose details of the recommendations. The company says it is on track to complete the CAPAs by the end of the quarter, and plans to resubmit the applications "thereafter."
The trastuzumab biosimilar (MYL-1401O, CANMab, Hertraz) and pegfilgrastim biosimilar (MYL-1401H) are 2 of 6 biosimilars that Biocon is co-developing with Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL) under a 2009 deal (see BioCentury, July 6, 2009)...