Towards the end of February, Biocon released a statement via the National Stock Exchange of India that an inspection by the US Food and Drug Administration (FDA) had resulted in three observations.
The Johor, Malaysia, site had been visited as part of a pre-approval inspection for its insulin glargine product, which the company plans to commercialize alongside Mylan.
However, the observations could have proved a stumbling block to entering the US market, though at the time Biocon had stated that it did not expect the inspection outcome to impact its plans for launching in the US.
Now, Biocon has provided an update that its insulin manufacturing facility had been closed with a ‘VAI’ (voluntary action indicated). As a result, the inspection of facility is closed by the FDA.
Mylan is currently proceeding with its application process to FDA for Semglee (insulin glargine)’s approval, with the potential product currently on review.
Semglee is currently approved in various countries globally, including in Europe as a biosimilar to existing insulin glargine products.
As of last month, the FDA will now review insulin products as biologics and therefore as biosimilars – though Mylan and Biocon are proceeding with a new drug application (NDA).