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How Biocon Site Prevented FDA 'OAI' Finding From Derailing Biosimilars

 
• By Anju Ghangurde

By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.

Compliance
AN FDA EIR PROVIDES INSIGHTS INTO BIOCON'S COMPLIANCE JOURNEY

US FDA had considered issuing an "official action indicated," or OAI, classification for a Biocon Ltd. facility in Bangalore, India, but after the firm addressed key issues raised during a May 25 through June 3 inspection, the agency instead closed out the inspection in November as "voluntary action indicated," or VAI.

If the agency had decided on an OAI classification, it could have potentially delayed approval of Mylan's biosimilar Herceptin (trastuzumab) and Neulasta (pegfilgrastim), which Biocon, India’s

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• By Neena Brizmohun

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More from Compliance

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• By Jessica Merrill

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