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

Executive Summary

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.

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Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

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Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site. 

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