Biocon insulin facility hit with FDA Form 483
The company provided a statement to the National Stock Exchange of India on the US Food and Drug Administration (FDA)’s inspection of its Johor, Malaysia facility.
The agency conducted the inspection between February 10 and 21, 2020, ahead of potential approval of the insulin glargine product that is produced at the site.
In response, Biocon noted that the three observations made in the Form 483, which is not currently public, were “procedural in nature” and that it would be able to address these observations ‘expeditiously’.
Further than this, the company stated, “The FDA has set a target action date for [its] insulin glargine application in June 2020. We believe the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the US.”
In August 2019, Biocon’s facility had passed an inspection by European authorities for the production of its insulin product to be delivered to Europe.
A month prior to this investigation, the FDA had raised concerns about the Malaysia facility, leading to 12 observations.
The facility itself started commercial operations in 2017, after an investment of approximately $275m (€250m). Upon completion, the site became the largest integrated insulin manufacturing facility in Asia and has a team of 600 professionals working on location.
Insugen and Basalog are two insulin biosimilars produced at the facility, which are housed within Biocon’s biologics subsidiary, Biocon Biologics.
Last month, the overall company announced it had received investment of $75m from True North, an Indian private equity fund, valuing the overall business at approximately $3bn.
With its insulin products awaiting US approval and with the FDA soon to recognize such products as biologics, Biocon Biologics anticipates that it could develop its annual revenues to approximately $1bn by 2022.